Prescription drug · ANDA
Adapalene NDC 46708-549
Adapalene 3 mg/g · Gel · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-549-15 | 46708054915 | 1 TUBE in 1 CARTON (46708-549-15) / 15 g in 1 TUBEMarketed from Mar 26, 2025 | |
| 46708-549-45 | 46708054945 | 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBEMarketed from Mar 26, 2025 | |
| 46708-549-46 | 46708054946 | 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMPMarketed from Mar 26, 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)
- Adapalene
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 3 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213508
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 46708-549_2601af7f-4657-41f1-9b14-0efda19c971bSPL ID 2601af7f-4657-41f1-9b14-0efda19c971bSPL set ID 5dd6d825-f7c4-4a86-82cc-fcbb41df8542RxCUI 722111UNII 1L4806J2QFUPC 0346708549459, 0346708549466
- 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
N446708054915followed by a unit qualifier and the quantityPackage 46708-0549-15. 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)
Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213508
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 |
|---|---|---|---|---|
| Adapalene | Adapalene 3 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-549 |