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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ADAPALENE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 722111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-549 | ADAPALENE GEL [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 6 package rows | 20250327_5dd6d825-f7c4-4a86-82cc-fcbb41df8542.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 46708-549-45 | 46708054945 | 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE | 1 tube | 2025-03-26 | No | No | Current |
| 46708-549-46 | 46708054946 | 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMP | | 2025-03-26 | No | No | Current |