Adapalene
- Product NDC
- 76162-114
- 11-digit product format
- 761620114
- Labeler code
- 76162
- Product ID
- 76162-114_144e4db6-6253-4c98-b571-ea1108c177d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Topco Associates
- Application
- ANDA090962
- Marketing category
- ANDA
- Marketing start
- 2023-11-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adapalene
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 307731 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-114-05 | Adapalene | 15 g in 1 TUBE | GEL | 15 | | 4 |
| 76162-114-05 | Adapalene | 1 in 1 CARTON | GEL | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-114 | ADAPALENE GEL [TOPCO ASSOCIATES] | 3 | Current NDC, 2 package rows | 20240302_5693e3c9-00e5-4e62-b44a-47be2dc31811.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 |
|---|
| 76162-114-05 | 76162011405 | 1 TUBE in 1 CARTON (76162-114-05) / 15 g in 1 TUBE | 1 tube | 2023-11-30 | No | No | Historical |