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NDC 63629-8635-01 Clindamycin Phosphate and Benzoyl Peroxide 25; 10 mg/g; mg/g Details
Clindamycin Phosphate and Benzoyl Peroxide 25; 10 mg/g; mg/g
Clindamycin Phosphate 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 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE.
Product Information
| NDC | 63629-8635 |
|---|---|
| Product ID | 63629-8635_00b68cb4-a998-8fe9-e063-6294a90abd17 |
| Associated GPIs | |
| GCN Sequence Number | 066978 |
| GCN Sequence Number Description | clindamycin phos/benzoyl perox GEL W/PUMP 1.2%-2.5% TOPICAL |
| HIC3 | L5H |
| HIC3 Description | ACNE AGENTS,TOPICAL |
| GCN | 29418 |
| HICL Sequence Number | 017263 |
| HICL Sequence Number Description | CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Clindamycin Phosphate and Benzoyl Peroxide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clindamycin Phosphate, Benzoyl Peroxide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 25; 10 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205397 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8635-01 (63629863501)
| NDC Package Code | 63629-8635-1 |
|---|---|
| Billing NDC | 63629863501 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (63629-8635-1) / 50 g in 1 BOTTLE, PUMP |
| Marketing Start Date | 2019-09-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |