Prescription drug · ANDA
Bexarotene NDC 43975-315
Bexarotene 75 mg/1 · Capsule, Liquid filled · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43975-315-10 | 43975031510 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (43975-315-10)Marketed from May 10, 2018 |
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, Liquid filled
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 43975
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209861
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 43975-315_07544503-a705-48cb-9a86-5bb5ece3fb91SPL ID 07544503-a705-48cb-9a86-5bb5ece3fb91SPL set ID e713c60d-f623-4260-b0ca-db07e1365fd2RxCUI 308725UNII A61RXM4375UPC 0343975315107
- 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
N443975031510followed by a unit qualifier and the quantityPackage 43975-0315-10. 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 43975-315
- What is NDC 43975-315?
- 43975-315 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, liquid filled, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 43975. 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 | Amneal Pharmaceuticals NY LLC | 69238-1250 | 69238-1250-01 |
| Bexarotene | Bexarotene 75 mg/1 | CapsuleOral | Upsher-Smith Laboratories, Inc. | 0832-0285 | 00832-0285-00 |
| Bexarotene | Bexarotene 75 mg/1 | Capsule, Liquid filledOral | Mylan Pharmaceuticals Inc. | 0378-6955 | 00378-6955-01 |