NDC 47848-039OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Rivaroxaban

FDA labeler: Teva Czech Industries s.r.o

33 formulations • 90 package configurations

All 123 registered NDCs — click to copy

In one line

Generic formulation (Rivaroxaban) NDC 47848-039 converts to 47848-0039-00 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk

Listing: 47848-039

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

47848-0039-00

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Every registered strength and package for Generic formulation, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
2.5 mg/1	50228-513-18	50228-513	50228-0513-18	180 TABLET, FILM COATED in 1 BOTTLE (50228-513-18)
2.5 mg/1	50228-513-60	50228-513	50228-0513-60	60 TABLET, FILM COATED in 1 BOTTLE (50228-513-60)
2.5 mg/1	60505-6256-5	60505-6256	60505-6256-05	500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5)
2.5 mg/1	60505-6256-6	60505-6256	60505-6256-06	60 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6)
2.5 mg/1	59651-849-18	59651-849	59651-0849-18	180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18)
2.5 mg/1	59651-849-60	59651-849	59651-0849-60	60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)
2.5 mg/1	68180-709-06	68180-709	68180-0709-06	30 TABLET, FILM COATED in 1 BOTTLE (68180-709-06)
2.5 mg/1	68180-709-09	68180-709	68180-0709-09	90 TABLET, FILM COATED in 1 BOTTLE (68180-709-09)
2.5 mg/1	76282-774-18	76282-774	76282-0774-18	180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18)
2.5 mg/1	76282-774-60	76282-774	76282-0774-60	60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60)
2.5 mg/1	62332-683-10	62332-683	62332-0683-10	100 BLISTER PACK in 1 CARTON (62332-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
2.5 mg/1	62332-683-45	62332-683	62332-0683-45	180 TABLET, FILM COATED in 1 BOTTLE (62332-683-45)
2.5 mg/1	62332-683-60	62332-683	62332-0683-60	60 TABLET, FILM COATED in 1 BOTTLE (62332-683-60)
2.5 mg/1	62332-683-91	62332-683	62332-0683-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-683-91)
2.5 mg/1	42571-345-05	42571-345	42571-0345-05	500 TABLET in 1 BOTTLE (42571-345-05)
2.5 mg/1	42571-345-30	42571-345	42571-0345-30	30 TABLET in 1 BOTTLE (42571-345-30)
2.5 mg/1	42571-345-60	42571-345	42571-0345-60	60 TABLET in 1 BOTTLE (42571-345-60)
2.5 mg/1	72205-416-02	72205-416	72205-0416-02	10 BLISTER PACK in 1 CARTON (72205-416-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK
2.5 mg/1	72205-416-03	72205-416	72205-0416-03	30 TABLET, FILM COATED in 1 BOTTLE (72205-416-03)
2.5 mg/1	72205-416-04	72205-416	72205-0416-04	60 TABLET, FILM COATED in 1 BOTTLE (72205-416-04)
2.5 mg/1	72205-416-05	72205-416	72205-0416-05	180 TABLET, FILM COATED in 1 BOTTLE (72205-416-05)
Outer kit carton	62332-240-51	62332-240	62332-0240-51	1 KIT in 1 CARTON (62332-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
2.5 mg/1	71921-405-06	71921-405	71921-0405-06	60 TABLET in 1 BOTTLE (71921-405-06)
2.5 mg/1	71921-405-21	71921-405	71921-0405-21	180 TABLET in 1 BOTTLE (71921-405-21)
15 mg/1	55488-0541-1	55488-0541	55488-0541-01	30 TABLET, FILM COATED in 1 BOTTLE (55488-0541-1)
10 mg/1	55488-0540-1	55488-0540	55488-0540-01	30 TABLET, FILM COATED in 1 BOTTLE (55488-0540-1)
2.5 mg/1	43598-981-18	43598-981	43598-0981-18	180 TABLET in 1 BOTTLE (43598-981-18)
2.5 mg/1	43598-981-60	43598-981	43598-0981-60	60 TABLET in 1 BOTTLE (43598-981-60)
2.5 mg/1	43598-981-78	43598-981	43598-0981-78	10 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79)
Inner component	43598-981-79	43598-981	43598-0981-79	Inner component of kit (43598-981-78)
20 mg/1	55488-0542-1	55488-0542	55488-0542-01	30 TABLET, FILM COATED in 1 BOTTLE (55488-0542-1)
Outer kit carton	46708-240-51	46708-240	46708-0240-51	1 KIT in 1 CARTON (46708-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
155 mg/1	67877-882-71	67877-882	67877-0882-71	1 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE
10 mg/1	62332-346-10	62332-346	62332-0346-10	100 BLISTER PACK in 1 CARTON (62332-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	62332-346-30	62332-346	62332-0346-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-346-30)
10 mg/1	62332-346-90	62332-346	62332-0346-90	90 TABLET, FILM COATED in 1 BOTTLE (62332-346-90)
10 mg/1	62332-346-91	62332-346	62332-0346-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-346-91)
15 mg/1	62332-347-10	62332-347	62332-0347-10	100 BLISTER PACK in 1 CARTON (62332-347-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
15 mg/1	62332-347-30	62332-347	62332-0347-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-347-30)
15 mg/1	62332-347-90	62332-347	62332-0347-90	90 TABLET, FILM COATED in 1 BOTTLE (62332-347-90)
15 mg/1	62332-347-91	62332-347	62332-0347-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-347-91)
20 mg/1	62332-348-10	62332-348	62332-0348-10	100 BLISTER PACK in 1 CARTON (62332-348-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
20 mg/1	62332-348-30	62332-348	62332-0348-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-348-30)
20 mg/1	62332-348-90	62332-348	62332-0348-90	90 TABLET, FILM COATED in 1 BOTTLE (62332-348-90)
20 mg/1	62332-348-91	62332-348	62332-0348-91	1000 TABLET, FILM COATED in 1 BOTTLE (62332-348-91)
2.5 mg/1	46708-683-10	46708-683	46708-0683-10	100 BLISTER PACK in 1 CARTON (46708-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
2.5 mg/1	46708-683-45	46708-683	46708-0683-45	180 TABLET, FILM COATED in 1 BOTTLE (46708-683-45)
2.5 mg/1	46708-683-60	46708-683	46708-0683-60	60 TABLET, FILM COATED in 1 BOTTLE (46708-683-60)
2.5 mg/1	46708-683-91	46708-683	46708-0683-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-683-91)
155 mg/1	70748-355-01	70748-355	70748-0355-01	1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE
2.5 mg/1	33342-488-09	33342-488	33342-0488-09	60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09)
2.5 mg/1	33342-488-57	33342-488	33342-0488-57	180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57)
2.5 mg/1	33342-488-98	33342-488	33342-0488-98	10 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK
2.5 mg/1	31722-496-18	31722-496	31722-0496-18	180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18)
2.5 mg/1	31722-496-60	31722-496	31722-0496-60	60 TABLET, FILM COATED in 1 BOTTLE (31722-496-60)
2.5 mg/1	72603-890-01	72603-890	72603-0890-01	60 TABLET, FILM COATED in 1 BOTTLE (72603-890-01)
2.5 mg/1	72603-890-02	72603-890	72603-0890-02	180 TABLET, FILM COATED in 1 BOTTLE (72603-890-02)
2.5 mg/1	72865-321-18	72865-321	72865-0321-18	180 TABLET, FILM COATED in 1 BOTTLE (72865-321-18)
2.5 mg/1	72865-321-60	72865-321	72865-0321-60	60 TABLET, FILM COATED in 1 BOTTLE (72865-321-60)
20 mg/1	46708-348-10	46708-348	46708-0348-10	100 BLISTER PACK in 1 CARTON (46708-348-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
20 mg/1	46708-348-30	46708-348	46708-0348-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-348-30)
20 mg/1	46708-348-90	46708-348	46708-0348-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-348-90)
20 mg/1	46708-348-91	46708-348	46708-0348-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-348-91)
10 mg/1	46708-346-10	46708-346	46708-0346-10	100 BLISTER PACK in 1 CARTON (46708-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	46708-346-30	46708-346	46708-0346-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-346-30)
10 mg/1	46708-346-90	46708-346	46708-0346-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-346-90)
10 mg/1	46708-346-91	46708-346	46708-0346-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-346-91)
15 mg/1	46708-347-10	46708-347	46708-0347-10	100 BLISTER PACK in 1 CARTON (46708-347-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
15 mg/1	46708-347-30	46708-347	46708-0347-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-347-30)
15 mg/1	46708-347-90	46708-347	46708-0347-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-347-90)
15 mg/1	46708-347-91	46708-347	46708-0347-91	1000 TABLET, FILM COATED in 1 BOTTLE (46708-347-91)
10 mg/1	14445-148-10	14445-148	14445-0148-10	10 BLISTER PACK in 1 CARTON (14445-148-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-148-02)
Inner component	14445-148-02	14445-148	14445-0148-02	Inner component of kit (14445-148-10)
10 mg/1	14445-148-30	14445-148	14445-0148-30	30 TABLET, FILM COATED in 1 BOTTLE (14445-148-30)
10 mg/1	14445-148-90	14445-148	14445-0148-90	90 TABLET, FILM COATED in 1 BOTTLE (14445-148-90)
2.5 mg/1	14445-147-10	14445-147	14445-0147-10	10 BLISTER PACK in 1 CARTON (14445-147-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-147-02)
Inner component	14445-147-02	14445-147	14445-0147-02	Inner component of kit (14445-147-10)
2.5 mg/1	14445-147-18	14445-147	14445-0147-18	180 TABLET, FILM COATED in 1 BOTTLE (14445-147-18)
2.5 mg/1	14445-147-60	14445-147	14445-0147-60	60 TABLET, FILM COATED in 1 BOTTLE (14445-147-60)
15 mg/1	14445-183-10	14445-183	14445-0183-10	10 BLISTER PACK in 1 CARTON (14445-183-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-183-02)
Inner component	14445-183-02	14445-183	14445-0183-02	Inner component of kit (14445-183-10)
15 mg/1	14445-183-30	14445-183	14445-0183-30	30 TABLET, FILM COATED in 1 BOTTLE (14445-183-30)
15 mg/1	14445-183-90	14445-183	14445-0183-90	90 TABLET, FILM COATED in 1 BOTTLE (14445-183-90)
2.5 mg/1	51672-4228-4	51672-4228	51672-4228-04	60 TABLET, COATED in 1 BOTTLE (51672-4228-4)
2.5 mg/1	51672-4228-9	51672-4228	51672-4228-09	180 TABLET, COATED in 1 BOTTLE (51672-4228-9)
20 mg/1	14445-184-00	14445-184	14445-0184-00	1000 TABLET, FILM COATED in 1 BOTTLE (14445-184-00)
20 mg/1	14445-184-10	14445-184	14445-0184-10	10 BLISTER PACK in 1 CARTON (14445-184-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-184-02)
Inner component	14445-184-02	14445-184	14445-0184-02	Inner component of kit (14445-184-10)
20 mg/1	14445-184-30	14445-184	14445-0184-30	30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30)
20 mg/1	14445-184-90	14445-184	14445-0184-90	90 TABLET, FILM COATED in 1 BOTTLE (14445-184-90)

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary. Initial U.S. approval: 2023.

Highlights

These highlights do not include all the information needed to use Generic formulation safely and effectively. The full sections follow.

Indications and usage: AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals.
Dosage and administration: For intramuscular use only. • After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). • Supplied as two presentations: (1) Vial of Lyophilized Antigen Component reconstituted with accompanying Adjuvant Suspension Component vial; (2) Vial of Lyophilized Antigen Component reconstituted with accompanying prefilled syringe of Adjuvant Suspension Component.
Dosage forms and strengths: For injectable suspension: Single dose after reconstitution is 0.5 mL (vial/vial) or approximately 0.5 mL (vial/prefilled syringe).
Contraindications: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Warnings and precautions: • Guillain-Barré Syndrome: Postmarketing observational study suggests an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. • Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions. • Syncope: Syncope (fainting) may occur; procedures should be in place to avoid injury from falling. • Altered Immunocompetence: Immunocompromised persons may have a diminished immune response.
Adverse reactions: • Most commonly reported adverse reactions (≥10%) in adults ≥60 years: injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). • In adults 50–59 years: injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%). • In adults 18–49 years: injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%).

13 Label Sections

INDICATIONS AND USAGE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals [see Use in Specific Populations (8.1)].

DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). 2.2 Preparation & Reconstitution Instructions AREXVY is supplied in two presentations that must be combined prior to administration: • Vial and Vial Presentation: Reconstitute the Lyophilized Antigen Component (sterile white powder) with the accompanying Adjuvant Suspension Component (opalescent, colorless to pale brownish liquid). Use only the supplied Adjuvant Suspension Component for reconstitution. Withdraw entire contents of adjuvant vial and slowly transfer into antigen powder vial. Gently swirl until completely dissolved. • Vial and Prefilled Syringe Presentation: Reconstitute the Lyophilized Antigen Component vial with the accompanying prefilled syringe of Adjuvant Suspension Component. Slowly transfer entire contents into antigen vial and gently swirl until powder dissolves. 2.3 Administration For intramuscular (IM) injection only, preferably in the deltoid region. After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

DOSAGE FORMS AND STRENGTHS

For injectable suspension. • For the vial and vial presentation, a single dose after reconstitution is 0.5 mL. • For the vial and prefilled syringe presentation, a single dose after reconstitution is approximately 0.5 mL.

CONTRAINDICATIONS

Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)].

WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY [see Adverse Reactions (6.2)]. 5.2 Preventing and Managing Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY. 5.3 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting. 5.4 Altered Immunocompetence Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

ADVERSE REACTIONS

6.1 Clinical Trials Experience The safety of AREXVY was evaluated in over 17,879 vaccine recipients in multi-center clinical trials (Study 1: NCT04886596 in 24,966 participants). Most Commonly Reported Solicited Adverse Reactions: • Adults ≥60 years: Injection site pain (60.9%), Fatigue (33.6%), Myalgia (28.9%), Headache (27.2%), Arthralgia (18.1%), Erythema (7.5%), Swelling (5.5%), Fever (2.0%). • Adults 50–59 years: Injection site pain (75.8%), Fatigue (39.8%), Myalgia (35.6%), Headache (31.7%), Arthralgia (23.4%), Erythema (13.2%), Swelling (10.4%). • Adults 18–49 years: Injection site pain (76.0%), Myalgia (59.9%), Fatigue (59.6%), Headache (43.6%), Arthralgia (28.3%). 6.2 Postmarketing Experience Postmarketing surveillance identified cases of Guillain-Barré syndrome and acute hypersensitivity reactions following administration.

DRUG INTERACTIONS & CONCOMITANT ADMINISTRATION

USE IN SPECIFIC POPULATIONS

DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

HOW SUPPLIED / STORAGE AND HANDLING

AREXVY is supplied as: • Outer Carton Kit (58160-848-11): 1 vial of Lyophilized Antigen Component (58160-723-03) and 1 vial of Adjuvant Suspension Component (58160-744-03). • Outer Carton Kit (58160-894-15): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). • Outer Carton Kit (58160-882-12): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). Storage before Reconstitution: Store in refrigerator between 2°C and 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Discard if frozen. Storage after Reconstitution: Use immediately or store in refrigerator at 2°C to 8°C or room temperature up to 25°C (77°F) for up to 4 hours.

PATIENT COUNSELING INFORMATION

Labeler

Teva Pharmaceuticals

Full NDC portfolio, brand list and J-code coverage for this manufacturer.

Open the labeler

Terms used here11-digit NDC Package NDC N4 qualifier

Search more NDCs & medical codes

NDC • HCPCS Level II • CPT administration

All registered strengths & packaging

Prescribing information

Highlights

Related

Teva Pharmaceuticals