clindamycin phosphate and benzoyl peroxide (21922-074)

Drug Facts

Product Profile

Brand Name clindamycin phosphate and benzoyl peroxide

Generic Name clindamycin phosphate and benzoyl peroxide

Labeler encube ethicals, inc.

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

benzoyl peroxide 25 mg/g, clindamycin phosphate 10 mg/g

Manufacturer

Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-074

Product ID 21922-074_9335260c-4e64-45c5-9bca-5ffc3db0eb16

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207194

Listing Expiration 2026-12-31

Marketing Start 2024-12-01

Pharmacologic Class

Classes

decreased sebaceous gland activity [pe] lincosamide antibacterial [epc] lincosamides [cs] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922074

Hyphenated Format 21922-074

Supplemental Identifiers

RxCUI

885131

UPC

0321922074406

UNII

W9WZN9A0GM EH6D7113I8

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clindamycin phosphate and benzoyl peroxide (source: ndc)

Generic Name clindamycin phosphate and benzoyl peroxide (source: ndc)

Application Number ANDA207194 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

25 mg/g
10 mg/g

source: ndc

Packaging

1 BOTTLE, PUMP in 1 CARTON (21922-074-40) / 50 g in 1 BOTTLE, PUMP

source: ndc

Packages (1)

21922-074-40 1 BOTTLE, PUMP in 1 CARTON (21922-074-40) / 50 g in 1 BOTTLE, PUMP

Ingredients (2)

benzoyl peroxide (25 mg/g) clindamycin phosphate (10 mg/g)

Linked Drug Pages (1)

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "9335260c-4e64-45c5-9bca-5ffc3db0eb16", "openfda": {"upc": ["0321922074406"], "unii": ["W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["885131"], "spl_set_id": ["977b2395-14ff-4c64-9a1e-77ef75805a83"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (21922-074-40)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "21922-074-40", "marketing_start_date": "20241201"}], "brand_name": "CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE", "product_id": "21922-074_9335260c-4e64-45c5-9bca-5ffc3db0eb16", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "21922-074", "generic_name": "CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "25 mg/g"}, {"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}], "application_number": "ANDA207194", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}