Adapalene
- Product NDC
- 63629-8791
- 11-digit product format
- 636298791
- Labeler code
- 63629
- Product ID
- 63629-8791_33b3377c-cc50-4734-8cfe-e6d828631856
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adapalene
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090824
- Marketing category
- ANDA
- Marketing start
- 2010-06-30
- Substance
- ADAPALENE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adapalene
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 313852 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8791-1 | Adapalene | 45 g in 1 TUBE | CREAM | 45 | | 104 |
| 63629-8791-1 | Adapalene | 1 in 1 CARTON | CREAM | 1 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8791 | ADAPALENE CREAM [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 2 package rows | 20240112_5f8189a2-a7ec-441b-993c-fed28b3ae24f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8791-1 | 63629879101 | 1 TUBE in 1 CARTON (63629-8791-1) / 45 g in 1 TUBE | 1 tube | 2010-06-30 | 0000-00-00 | No | No | Current |