Prescription drug · ANDA
Bexarotene NDC 0832-0285
Bexarotene 75 mg/1 · Capsule · Oral · Upsher-Smith Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0285-00 | 00832028500 | 100 CAPSULE in 1 BOTTLE (0832-0285-00)Marketed from Jul 25, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Upsher-Smith Laboratories, Inc.NDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209886
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0832-0285_0392c67b-a83c-4e6c-95d6-09604953652dSPL ID 0392c67b-a83c-4e6c-95d6-09604953652dSPL set ID 7437a43f-172a-4f4e-8132-fe23b00224f9RxCUI 308725UNII A61RXM4375UPC 0308320285009
- 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
N400832028500followed by a unit qualifier and the quantityPackage 00832-0285-00. 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 0832-0285
- What is NDC 0832-0285?
- 0832-0285 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, listed with the FDA by Upsher-Smith Laboratories, 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?
- Upsher-Smith Laboratories, Inc., NDC labeler code 0832. 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 | 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 |