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NDC 63629-8607-01 adapalene and benzoyl peroxide .1; 2.5 g/100g; g/100g Details
adapalene and benzoyl peroxide .1; 2.5 g/100g; g/100g
adapalene and benzoyl peroxide is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-8607-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Adapalene
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 63629-8607-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 63629-8607 |
|---|---|
| Product ID | 63629-8607_00b266d9-ac2c-e931-e063-6294a90a6a0b |
| Associated GPIs | |
| GCN Sequence Number | 068880 |
| GCN Sequence Number Description | adapalene/benzoyl peroxide GEL W/PUMP 0.1 %-2.5% TOPICAL |
| HIC3 | L5H |
| HIC3 Description | ACNE AGENTS,TOPICAL |
| GCN | 31775 |
| 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 | .1; 2.5 |
| Active Ingredient Units | g/100g; g/100g |
| Substance Name | ADAPALENE; BENZOYL PEROXIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205033 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8607-01 (63629860701)
| NDC Package Code | 63629-8607-1 |
|---|---|
| Billing NDC | 63629860701 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (63629-8607-1) / 45 g in 1 BOTTLE, PUMP |
| Marketing Start Date | 2018-01-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |