Adapalene and benzoyl peroxide
- Product NDC
- 70771-1716
- 11-digit product format
- 707711716
- Labeler code
- 70771
- Product ID
- 70771-1716_2825a88e-4c88-4703-9128-ad478f3aae28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene and benzoyl peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214553
- Marketing category
- ANDA
- Marketing start
- 2022-06-06
- 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 |
|---|
| 70771-1716-3 | Adapalene and benzoyl peroxide | 1 in 1 BOTTLE, PUMP | GEL | 1 | | 3 |
| 70771-1716-3 | Adapalene and benzoyl peroxide | 60 g in 1 BOTTLE, PUMP | GEL | 60 | | 3 |
| 70771-1716-4 | Adapalene and benzoyl peroxide | 1 in 1 BOTTLE, PUMP | GEL | 1 | | 3 |
| 70771-1716-4 | Adapalene and benzoyl peroxide | 45 g in 1 BOTTLE, PUMP | GEL | 45 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1716 | ADAPALENE AND BENZOYL PEROXIDE GEL [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240817_d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1716-3 | 70771171603 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMP | 2022-06-06 | 0000-00-00 | No | No | Current |
| 70771-1716-4 | 70771171604 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 45 g in 1 BOTTLE, PUMP | 2022-06-06 | 0000-00-00 | No | No | Current |