What is NDC 54348-819?

54348-819 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by PharmPak, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

PharmPak, Inc., NDC labeler code 54348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ondansetron?

190 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ondansetron NDC 54348-819 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-819Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0819Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
54348-819-00	5434808190054348081900	1 BOTTLE in 1 BOX (54348-819-00) / 1 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019
54348-819-02	5434808190254348081902	1 BOTTLE in 1 BOX (54348-819-02) / 2 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019
54348-819-04	5434808190454348081904	1 BOTTLE in 1 BOX (54348-819-04) / 4 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019
54348-819-06	5434808190654348081906	1 BOTTLE in 1 BOX (54348-819-06) / 6 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019
54348-819-08	5434808190854348081908	1 BOTTLE in 1 BOX (54348-819-08) / 8 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ondansetron
Generic name (nonproprietary): ondansetron
Active ingredients: Ondansetron hydrochloride — 4 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: PharmPak, Inc.NDC labeler code 54348
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
Marketing start: Jul 10, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 54348-819_eaa5779b-4250-01ba-e053-2a95a90ae500SPL ID eaa5779b-4250-01ba-e053-2a95a90ae500SPL set ID 8e289184-6046-4b55-97d2-cb276d5782d5RxCUI 198052UNII NMH84OZK2B
Pharmacologic class: Serotonin-3 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454348081900 followed by a unit qualifier and the quantity

Package 54348-0819-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 9, 2022.

Indications (excerpt from the label)

Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54348-819

What is NDC 54348-819?: 54348-819 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by PharmPak, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ondansetron.
What is the active ingredient?: Ondansetron hydrochloride.
Who is the labeler?: PharmPak, Inc., NDC labeler code 54348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ondansetron?: 190 other product NDCs are listed under this name. See all Ondansetron NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ondansetron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	REMEDYREPACK INC.	70518-4685	70518-4685-00
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Preferred Pharmaceuticals Inc.	68788-4133	68788-4133-0168788-4133-03
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4882	00121-4882-94
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0882	00121-0882-51
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	JVET PHARMACEUTICALS LLC	86211-115	86211-0115-01
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4588	70518-4588-00
Ondansetron	Ondansetron hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2271	00409-2271-25
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-457	42291-0457-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-458	42291-0458-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	St. Mary's Medical Park Pharmacy	60760-936	60760-0936-10

All 191 Ondansetron NDCs

Other NDCs under ANDA 078539

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078539
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8651
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-119
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Pharmpak, Inc.	54348-821
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-878
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9368
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9402
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-076
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-075
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-792
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3511
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-034
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-179
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1585
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-744
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1596
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4145
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6342
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-813
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1562
Ondansetron HCL	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0072

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