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NDC 36800-0088-05 Adapalene 1 mg/g Details
Adapalene 1 mg/g
Adapalene is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by TOP CARE (Topco Associates LLC). The primary component is ADAPALENE.
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: 36800-0088-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Adapalene
Product Information
| NDC | 36800-0088 |
|---|---|
| Product ID | 36800-088_eaf6cd8c-63b5-42e9-aeaa-e911c19b9e4c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Adapalene |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Adapalene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/g |
| Substance Name | ADAPALENE |
| Labeler Name | TOP CARE (Topco Associates LLC) |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091314 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0088-05 (36800008805)
| NDC Package Code | 36800-088-05 |
|---|---|
| Billing NDC | 36800008805 |
| Package | 1 TUBE in 1 CARTON (36800-088-05) / 15 g in 1 TUBE |
| Marketing Start Date | 2020-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |