Adapalene
- Product NDC
- 51316-114
- 11-digit product format
- 513160114
- Labeler code
- 51316
- Product ID
- 51316-114_9f814bf1-58b8-4438-a8b0-e1c91bfe7dea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA090962
- Marketing category
- ANDA
- Marketing start
- 2023-10-31
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-114 | ADAPALENE GEL [CVS PHARMACY, INC] | 3 | Current NDC, 4 package rows | 20240223_ff9a929e-121b-42b4-8e79-f8f46c22a8be.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 |
|---|
| 51316-114-05 | 51316011405 | 1 TUBE in 1 CARTON (51316-114-05) / 15 g in 1 TUBE | 1 tube | 2023-10-31 | No | No | Current |
| 51316-114-16 | 51316011416 | 1 TUBE in 1 CARTON (51316-114-16) / 45 g in 1 TUBE | 1 tube | 2023-10-31 | No | No | Current |