ADAPALENE
- Product NDC
- 46708-549
- 11-digit product format
- 467080549
- Labeler code
- 46708
- Product ID
- 46708-549_2601af7f-4657-41f1-9b14-0efda19c971b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ADAPALENE
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213508
- Marketing category
- ANDA
- Marketing start
- 2025-03-26
- Substance
- ADAPALENE
- Active strength
- 3 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1L4806J2QF | ADAPALENE | 106685-40-9 | ADAPALENE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-549-15 | 46708054915 | 1 TUBE in 1 CARTON (46708-549-15) / 15 g in 1 TUBE | 1 tube | 2025-03-26 | No | No | Historical |
| 46708-549-45 | 46708054945 | 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE | 1 tube | 2025-03-26 | No | No | Historical |
| 46708-549-46 | 46708054946 | 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMP | | 2025-03-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ADAPALENE | Alembic Pharmaceuticals Limited | 2025-03-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |