Adapalene
- Product NDC
- 46122-768
- 11-digit product format
- 461220768
- Labeler code
- 46122
- Product ID
- 46122-768_38f457fa-0e98-7298-e063-6394a90adda8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- AMERISOURCE BERGEN
- Application
- ANDA215940
- Marketing category
- ANDA
- Marketing start
- 2024-02-26
- Substance
- ADAPALENE
- Active strength
- 1 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 |
|---|
| 46122-768-36 | 46122076836 | 1 TUBE in 1 CARTON (46122-768-36) / 15 g in 1 TUBE | 1 tube | 2024-02-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Adapalene | AMERISOURCE BERGEN | Sun Pharma Canada Inc. | 2025-07-02 | HUMAN OTC DRUG LABEL | 2 |