Adapalene
- Product NDC
- 80861-115
- 11-digit product format
- 808610115
- Labeler code
- 80861
- Product ID
- 80861-115_3aaef113-7ec1-ba6b-e063-6394a90a67e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Adaplane 0.1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Acne Free, LLC
- Application
- ANDA091314
- Marketing category
- ANDA
- Marketing start
- 2024-01-05
- Substance
- ADAPALENE
- Active strength
- .1 g/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 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80861-115-01 | Adapalene | 1 g in 1 TUBE | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80861-115 | ADAPALENE (ADAPLANE 0.1%) GEL [ACNE FREE, LLC] | 2 | Current NDC, 1 package rows | 20240620_0dc574e0-397a-7bc8-e063-6394a90a27e2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80861-115-01 | 80861011501 | 1 g in 1 TUBE (80861-115-01) | 1 g | 2024-01-05 | No | No | Historical |