Adapalene and benzoyl peroxide
- Product NDC
- 0480-3154
- 11-digit product format
- 004803154
- Labeler code
- 0480
- Product ID
- 0480-3154_1ad8499d-f5e7-4ea0-86dc-8b451f52cfab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene and benzoyl peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA209641
- Marketing category
- ANDA
- Marketing start
- 2022-11-28
- Marketing end
- 2027-02-28
- Substance
- ADAPALENE; BENZOYL PEROXIDE
- Active strength
- 3; 25 mg/g; 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 and benzoyl peroxide
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 |
|---|
| 0480-3154-45 | Adapalene and benzoyl peroxide | 1 in 1 CARTON | GEL | 1 | | 2 |
| 0480-3154-45 | Adapalene and benzoyl peroxide | 45 g in 1 BOTTLE, PUMP | GEL | 45 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3154 | ADAPALENE AND BENZOYL PEROXIDE GEL [TEVA PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221129_05babd5f-18ab-4646-8962-cb000ed0f9a8.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 |
|---|
| 0480-3154-45 | 00480315445 | 1 BOTTLE, PUMP in 1 CARTON (0480-3154-45) / 45 g in 1 BOTTLE, PUMP | 2022-11-28 | 2027-02-28 | No | No | Current |