Prescription drug · NDA
Vraylar (Cariprazine) NDC 61874-170
Kit · Oral · Allergan, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Vraylar
- Generic name (nonproprietary)
- cariprazine
- Dosage form
- Kit
- 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 61874-170_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
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.
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 61874-170
- What is NDC 61874-170?
- 61874-170 is the product NDC for Vraylar (cariprazine) kit, listed with the FDA by Allergan, Inc..
- What drug is associated with this NDC?
- Vraylar (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 1.5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-115 | 61874-0115-0761874-0115-1761874-0115-20+1 more |
| 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 |
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 1.5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-115 |
| Vraylarcariprazine | Cariprazine 3 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-130 |
| Vraylarcariprazine | Cariprazine 4.5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-145 |
| Vraylarcariprazine | Cariprazine 6 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-160 |
| Vraylarcariprazine | Cariprazine .5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-250 |
| Vraylarcariprazine | Cariprazine .75 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-275 |