Prescription drug · ANDA
Brexpiprazole NDC 27241-208
Brexpiprazole 3 mg/1 · Tablet · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-208-30 | 27241020830 | 30 TABLET in 1 BOTTLE (27241-208-30)Marketed from Feb 3, 2023 |
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)
- Brexpiprazole
- Generic name (nonproprietary)
- brexpiprazole
- Active ingredients
- Brexpiprazole — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.NDC labeler code 27241
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213718
- Marketing start
- Listing expires
- Identifiers
- Product ID 27241-208_430dc8c4-7349-42d5-9036-b0bdcc02a839SPL ID 430dc8c4-7349-42d5-9036-b0bdcc02a839SPL set ID 993b584c-7fe6-4551-899f-39146c8508acRxCUI 1658319, 1658327, 1658331, 1658335, 1658339, 1658343UNII 2J3YBM1K8CUPC 0327241205309, 0327241208300, 0327241209307, 0327241206306, 0327241207303, 0327241204302
- 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
N427241020830followed by a unit qualifier and the quantityPackage 27241-0208-30. 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)
Brexpiprazole tablets are indicated for: Adjunctive treatment of major depressive disorder (MDD) in adults. Treatment of schizophrenia in adults. Brexpiprazole tablets is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults
Excerpt only. Read the full label for complete information.
About NDC 27241-208
- What is NDC 27241-208?
- 27241-208 is the product NDC for Brexpiprazole, Brexpiprazole 3 mg/1 tablet, listed with the FDA by Ajanta Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brexpiprazole.
- What is the active ingredient?
- Brexpiprazole.
- Who is the labeler?
- Ajanta Pharma USA Inc., NDC labeler code 27241. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brexpiprazole?
- 5 other product NDCs are listed under this name. See all Brexpiprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brexpiprazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brexpiprazole | Brexpiprazole .25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-204 | 27241-0204-30 |
| Brexpiprazole | Brexpiprazole .5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-205 | 27241-0205-30 |
| Brexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-206 | 27241-0206-30 |
| Brexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-207 | 27241-0207-30 |
| Brexpiprazole | Brexpiprazole 4 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-209 | 27241-0209-30 |
Other NDCs under ANDA 213718
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 |
|---|---|---|---|---|
| Brexpiprazole | Brexpiprazole .5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-205 |
| Brexpiprazole | Brexpiprazole .25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-204 |
| Brexpiprazole | Brexpiprazole 4 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-209 |
| Brexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-206 |
| Brexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-207 |