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.
- 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.
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 6 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-160 |
| 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 .5 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-250 |
| Vraylarcariprazine | Cariprazine .75 mg/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 61874-275 |