Prescription drug · NDA
Vraylar (Cariprazine) NDC 61874-115
Cariprazine 1.5 mg/1 · Capsule, Gelatin coated · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61874-115-07 | 61874011507 | 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07)Marketed from Mar 1, 2016 · Sample package | |
| 61874-115-17 | 61874011517 | 1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACKMarketed from Mar 1, 2016 | |
| 61874-115-20 | 61874011520 | 2 BLISTER PACK in 1 CARTON (61874-115-20) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-11)Marketed from Mar 1, 2016 | |
| 61874-115-30 | 61874011530 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-115-30)Marketed from Mar 1, 2016 |
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)
- Vraylar
- Generic name (nonproprietary)
- cariprazine
- Active ingredients
- Cariprazine — 1.5 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 61874
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204370
- Marketing start
- Listing expires
- Identifiers
- Product ID 61874-115_ef3db4f6-9b04-4ffe-b72e-7ab3ceccb224SPL ID ef3db4f6-9b04-4ffe-b72e-7ab3ceccb224SPL set ID 4b5f7c65-aa2d-452a-b3db-bc85c06ff12fRxCUI 1667660, 1667666, 1667668, 1667670, 1667672, 1667674, 1667676, 1667678, 1741746, 1741747, 2729792, 2729794, 2729796, 2729798UNII F6RJL8B278UPC 0361874250305
- Pharmacologic class
- Atypical Antipsychotic
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
N461874011507followed by a unit qualifier and the quantityPackage 61874-0115-07. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] • Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizoph…
Excerpt only. Read the full label for complete information.
About NDC 61874-115
- What is NDC 61874-115?
- 61874-115 is the product NDC for Vraylar (cariprazine), Cariprazine 1.5 mg/1 capsule, gelatin coated, listed with the FDA by Allergan, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vraylar (Cariprazine).
- What is the active ingredient?
- Cariprazine.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 61874. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vraylar?
- 6 other product NDCs are listed under this name. See all Vraylar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vraylar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vraylarcariprazine | Cariprazine .5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-250 | 61874-0250-30 |
| Vraylarcariprazine | Cariprazine .75 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-275 | 61874-0275-30 |
| Vraylarcariprazine | Cariprazine 3 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-130 | 61874-0130-0761874-0130-2061874-0130-30 |
| Vraylarcariprazine | Cariprazine 4.5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-145 | 61874-0145-0761874-0145-30 |
| Vraylarcariprazine | Cariprazine 6 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-160 | 61874-0160-0761874-0160-30 |
| Vraylarcariprazine | — | KitOral | Allergan, Inc. | 61874-170 | — |
Other NDCs under NDA 204370
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vraylarcariprazine | Cariprazine 4.5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-145 |
| Vraylarcariprazine | Cariprazine 3 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-130 |
| Vraylarcariprazine | Cariprazine .75 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-275 |
| Vraylarcariprazine | Cariprazine 6 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-160 |
| Vraylarcariprazine | — | KitOral | Allergan, Inc. | 61874-170 |
| Vraylarcariprazine | Cariprazine .5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-250 |