Adapalene
- Product NDC
- 36800-088
- 11-digit product format
- 368000088
- Labeler code
- 36800
- Product ID
- 36800-088_20dcb442-f0fd-477b-8aef-c2cbf3afadcb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- ANDA091314
- Marketing category
- ANDA
- Marketing start
- 2020-07-30
- Marketing end
- 2026-10-01
- Substance
- ADAPALENE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adapalene
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 |
|---|
| 36800-088-05 | Adapalene | 15 g in 1 TUBE | GEL | 15 | | 3 |
| 36800-088-05 | Adapalene | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-088 | ADAPALENE GEL [TOP CARE (TOPCO ASSOCIATES LLC)] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221129_07351ab9-ed46-4ef8-85f3-bb6cc7af17c3.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 |
|---|
| 36800-088-05 | 36800008805 | 1 TUBE in 1 CARTON (36800-088-05) / 15 g in 1 TUBE | 1 tube | 2020-07-30 | 2026-10-01 | No | No | Current |