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NDC 68462-0301-55 adapalene and benzoyl peroxide 1; 25 mg/g; mg/g Details
adapalene and benzoyl peroxide 1; 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 Glenmark Pharmaceuticals Inc., USA. 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: 68462-0301-55Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Adapalene
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 68462-0301-55Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 68462-0301 |
|---|---|
| Product ID | 68462-301_597d44e5-14c5-4e81-b693-3725f8f4a39f |
| Associated GPIs | 90059902034020 |
| 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; 25 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | ADAPALENE; BENZOYL PEROXIDE |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208108 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68462-0301-55 (68462030155)
| NDC Package Code | 68462-301-55 |
|---|---|
| Billing NDC | 68462030155 |
| Package | 45 g in 1 TUBE (68462-301-55) |
| Marketing Start Date | 2019-11-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |