Prescription drug · ANDA
Tretinoin NDC 59651-713
Tretinoin .25 mg/g · Gel · Topical · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-713-14 | 59651071314 | 1 TUBE in 1 CARTON (59651-713-14) / 15 g in 1 TUBEMarketed from Feb 27, 2025 | |
| 59651-713-46 | 59651071346 | 1 TUBE in 1 CARTON (59651-713-46) / 45 g in 1 TUBEMarketed from Feb 27, 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
- Gel
- Route
- Topical
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218245
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 59651-713_50b05c90-bdd9-4766-b285-52bd88c4c740SPL ID 50b05c90-bdd9-4766-b285-52bd88c4c740SPL set ID dea325b5-3cb8-4ffb-84e9-782f0e3f6b0eRxCUI 313451UNII 5688UTC01RUPC 0359651713143
- 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
N459651071314followed by a unit qualifier and the quantityPackage 59651-0713-14. 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 gel 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.