Prescription drug · ANDA
Bexarotene NDC 69238-1250
Bexarotene 75 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1250-1 | 69238125001 | 1 BOTTLE in 1 CARTON (69238-1250-1) / 100 CAPSULE in 1 BOTTLEMarketed from Sep 4, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- 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 69238-1250_9e70a6ae-538e-406a-9814-a0a21121ba3dSPL ID 9e70a6ae-538e-406a-9814-a0a21121ba3dSPL set ID d7fc7c7b-2ecf-4543-8bb4-9b4415d66613RxCUI 308725UNII A61RXM4375UPC 0369238125016
- 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
N469238125001followed by a unit qualifier and the quantityPackage 69238-1250-01. 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.
About NDC 69238-1250
- What is NDC 69238-1250?
- 69238-1250 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bexarotene.
- What is the active ingredient?
- Bexarotene.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bexarotene?
- 7 other product NDCs are listed under this name. See all Bexarotene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bexarotene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bexarotene | Bexarotene 75 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-380 | 31722-0380-01 |
| Bexarotene | Bexarotene 75 mg/1 | CapsuleOral | AvKARE | 42291-072 | 42291-0072-01 |
| Bexarotene | Bexarotene 10 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2088 | 69238-2088-06 |
| bexarotene | Bexarotene 75 mg/1 | Capsule, Liquid filledOral | Actavis Pharma, Inc. | 0591-2832 | 00591-2832-01 |
| Bexarotene | Bexarotene 75 mg/1 | CapsuleOral | Upsher-Smith Laboratories, Inc. | 0832-0285 | 00832-0285-00 |
| Bexarotene | Bexarotene 75 mg/1 | Capsule, Liquid filledOral | ANI Pharmaceuticals, Inc. | 43975-315 | 43975-0315-10 |
| Bexarotene | Bexarotene 75 mg/1 | Capsule, Liquid filledOral | Mylan Pharmaceuticals Inc. | 0378-6955 | 00378-6955-01 |
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 | AvKARE | 42291-072 |