ADAPALENE AND BENZOYL PEROXIDE
- Product NDC
- 46708-662
- 11-digit product format
- 467080662
- Labeler code
- 46708
- Product ID
- 46708-662_528fc681-2ba1-442f-812f-339f90b0a030
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adapalene and benzoyl peroxide topical
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA214185
- Marketing category
- ANDA
- Marketing start
- 2025-05-21
- Substance
- ADAPALENE; BENZOYL PEROXIDE
- Active strength
- 3; 25 mg/g; 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 AND BENZOYL PEROXIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 3 mg/g |
| BENZOYL PEROXIDE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF, W9WZN9A0GM |
| Rxcui | 1663745 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-662-45 | ADAPALENE AND BENZOYL PEROXIDE | 1 in 1 CARTON | GEL | 1 | | 1 |
| 46708-662-45 | ADAPALENE AND BENZOYL PEROXIDE | 45 g in 1 BOTTLE, PUMP | GEL | 45 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-662-45 | 46708066245 | 1 BOTTLE, PUMP in 1 CARTON (46708-662-45) / 45 g in 1 BOTTLE, PUMP | 2025-05-21 | No | No | Current |