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NDC 51672-1384-04 Adapalene and Benzoyl Peroxide 3; 25 mg/g; mg/g Details
Adapalene and Benzoyl Peroxide 3; 25 mg/g; mg/g
Adapalene and Benzoyl Peroxide is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is ADAPALENE; BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.
Related Packages: 51672-1384-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Adapalene
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 51672-1384-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 51672-1384 |
|---|---|
| Product ID | 51672-1384_8b95551a-4272-47ed-b3b6-7155df5e43eb |
| Associated GPIs | 90059902034030 |
| GCN Sequence Number | 074495 |
| GCN Sequence Number Description | adapalene/benzoyl peroxide GEL W/PUMP 0.3 %-2.5% TOPICAL |
| HIC3 | L5H |
| HIC3 Description | ACNE AGENTS,TOPICAL |
| GCN | 39163 |
| HICL Sequence Number | 036015 |
| HICL Sequence Number Description | ADAPALENE/BENZOYL PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Adapalene and Benzoyl Peroxide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ADAPALENE and BENZOYL PEROXIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 25 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | ADAPALENE; BENZOYL PEROXIDE |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209148 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 51672-1384-04 (51672138404)
| NDC Package Code | 51672-1384-4 |
|---|---|
| Billing NDC | 51672138404 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (51672-1384-4) / 60 g in 1 BOTTLE, PUMP |
| Marketing Start Date | 2021-03-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |