Prescription drug · ANDA
Tretinoin NDC 46708-807
Tretinoin 1 mg/g · Cream · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-807-20 | 46708080720 | 1 TUBE in 1 CARTON (46708-807-20) / 20 g in 1 TUBEMarketed from Apr 25, 2025 | |
| 46708-807-45 | 46708080745 | 1 TUBE in 1 CARTON (46708-807-45) / 45 g in 1 TUBEMarketed from Apr 25, 2025 |
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)
- Tretinoin
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217804
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 46708-807_f46af408-0e68-4a78-8928-fc655c54d0c4SPL ID f46af408-0e68-4a78-8928-fc655c54d0c4SPL set ID 7845d60d-7c4c-4854-a417-6d3ea86a710fRxCUI 198300UNII 5688UTC01RUPC 0346708807450
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708080720followed by a unit qualifier and the quantityPackage 46708-0807-20. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217804
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 |
|---|---|---|---|---|
| Tretinoin | Tretinoin 1 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-807 |