Prescription drug · ANDA
Acitretin NDC 62332-743
Acitretin 25 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-743-30 | 62332074330 | 30 CAPSULE in 1 BOTTLE (62332-743-30)Marketed from Aug 8, 2024 |
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)
- Acitretin
- Generic name (nonproprietary)
- acitretin
- Active ingredients
- Acitretin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217774
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 62332-743_1235e7ee-d6db-440e-a680-999dc3295d2eSPL ID 1235e7ee-d6db-440e-a680-999dc3295d2eSPL set ID 0a4ca401-6ea4-4653-8674-056fa637f4a1RxCUI 199689, 199690, 894859UNII LCH760E9T7UPC 0362332742301
- 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
N462332074330followed by a unit qualifier and the quantityPackage 62332-0743-30. 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)
INDICATIONS AND USAGE Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — acitretin capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217774
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 |
|---|---|---|---|---|
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-742 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-741 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-742 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-741 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-743 |