Prescription drug · ANDA
Acitretin NDC 42291-086
Acitretin 10 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-086-30 | 42291008630 | 30 CAPSULE in 1 BOTTLE (42291-086-30)Marketed from Oct 11, 2017 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204633
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 42291-086_0e8b3503-2371-af12-e063-6294a90af0c0SPL ID 0e8b3503-2371-af12-e063-6294a90af0c0SPL set ID 6af396c2-af3e-436d-ba9a-583637495910RxCUI 199689, 199690, 894859UNII LCH760E9T7UPC 0342291086302, 0342291087309, 0342291088306
- 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
N442291008630followed by a unit qualifier and the quantityPackage 42291-0086-30. 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, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP 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, USP can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204633
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 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2222 |
| Acitretin | Acitretin 10 mg/1 | CapsuleOral | Sigmapharm Laboratories, LLC | 42794-080 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Sigmapharm Laboratories, LLC | 42794-081 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | Sigmapharm Laboratories, LLC | 42794-083 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | AvKARE | 42291-087 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2223 |
| Acitretin | Acitretin 25 mg/1 | CapsuleOral | AvKARE | 42291-088 |
| Acitretin | Acitretin 17.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2224 |