Prescription drug · ANDA
Tretinoin NDC 46708-809
Tretinoin .25 mg/g · Cream · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-809-20 | 46708080920 | 1 TUBE in 1 CARTON (46708-809-20) / 20 g in 1 TUBEMarketed from Aug 16, 2025 | |
| 46708-809-45 | 46708080945 | 1 TUBE in 1 CARTON (46708-809-45) / 45 g in 1 TUBEMarketed from Aug 16, 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 — .25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218399
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 46708-809_dc155719-fc32-4f08-a9db-b59da2f80759SPL ID dc155719-fc32-4f08-a9db-b59da2f80759SPL set ID 4e96fb71-14f4-4789-91af-ba94b0879162RxCUI 106302UNII 5688UTC01RUPC 0346708809454
- 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
N446708080920followed by a unit qualifier and the quantityPackage 46708-0809-20. 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 218399
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 .25 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-809 |