Adapalene and Benzoyl Peroxide
- Product NDC
- 0472-0310
- 11-digit product format
- 004720310
- Labeler code
- 0472
- Product ID
- 0472-0310_7621bbb4-7449-47d8-bdf3-b103bc7335e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adapalene and Benzoyl Peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203790
- Marketing category
- ANDA
- Marketing start
- 2017-07-27
- Marketing end
- 0000-00-00
- Substance
- ADAPALENE; BENZOYL PEROXIDE
- Active strength
- 1 mg/g; mg/g
- Pharmacologic classes
- Retinoid [EPC],Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0472-0310 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0472-0310 | 0472-0310-38 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0472-0310 | 0472-0310-45 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A203790-001 | ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL / TOPICAL | | | 2015-09-30 |