Prescription drug · ANDA
Bexarotene NDC 42291-072
Bexarotene 75 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-072-01 | 42291007201 | 100 CAPSULE in 1 BOTTLE (42291-072-01)Marketed from Apr 14, 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)
- Bexarotene
- Generic name (nonproprietary)
- bexarotene
- Active ingredients
- Bexarotene — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210105
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 42291-072_41163fef-69b8-4e09-e063-6294a90ac8acSPL ID 41163fef-69b8-4e09-e063-6294a90ac8acSPL set ID f9514265-6e2c-9030-e053-6394a90aa04bRxCUI 308725UNII A61RXM4375UPC 0342291072015
- Pharmacologic class
- Retinoid
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
N442291007201followed by a unit qualifier and the quantityPackage 42291-0072-01. 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)
Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Bexarotene capsules are a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210105
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 |
|---|---|---|---|---|
| Bexarotene | Bexarotene 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1250 |