Adapalene
- Product NDC
- 51672-1377
- 11-digit product format
- 516721377
- Labeler code
- 51672
- Product ID
- 51672-1377_38f40203-5ac8-283b-e063-6394a90a0e0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208322
- Marketing category
- ANDA
- Marketing start
- 2016-06-23
- Substance
- ADAPALENE
- Active strength
- 3 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF |
| Rxcui | 722111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1377-6 | Adapalene | 1 in 1 CARTON | GEL | 1 | | 8 |
| 51672-1377-6 | Adapalene | 45 g in 1 TUBE | GEL | 45 | | 8 |
| 51672-1377-9 | Adapalene | 1 in 1 CARTON | GEL | 1 | | 8 |
| 51672-1377-9 | Adapalene | 45 g in 1 BOTTLE, PUMP | GEL | 45 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1377 | ADAPALENE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250406_ca37576a-09aa-4ee8-9dc4-8ad76b999fcf.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-1377-6 | 51672137706 | 1 TUBE in 1 CARTON (51672-1377-6) / 45 g in 1 TUBE | 1 tube | 2016-06-23 | 0000-00-00 | No | No | Current |
| 51672-1377-9 | 51672137709 | 1 BOTTLE, PUMP in 1 CARTON (51672-1377-9) / 45 g in 1 BOTTLE, PUMP | | 2016-06-23 | 0000-00-00 | No | No | Current |