clindamycin phosphate and benzoyl peroxide clindamycin phosphate and benzoyl peroxide

Generic: clindamycin phosphate and benzoyl peroxide

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate and benzoyl peroxide 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 50 mg/g, clindamycin phosphate 10 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-022
Product ID 21922-022_c3c0a548-d788-41fc-b2f8-99431a48cd05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212433
Listing Expiration 2026-12-31
Marketing Start 2021-05-20

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 21922022
Hyphenated Format 21922-022

Supplemental Identifiers

RxCUI
1540241
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 clindamycin phosphate and benzoyl peroxide (source: ndc)
Generic Name clindamycin phosphate and benzoyl peroxide (source: ndc)
Application Number ANDA212433 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-022-06) / 45 g in 1 TUBE
source: ndc

Packages (1)

21922-022-06 1 TUBE in 1 CARTON (21922-022-06) / 45 g in 1 TUBE

Ingredients (2)

benzoyl peroxide (50 mg/g) clindamycin phosphate (10 mg/g)

Linked Drug Pages (1)

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c3c0a548-d788-41fc-b2f8-99431a48cd05", "openfda": {"unii": ["W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["1540241"], "spl_set_id": ["8ca01174-431e-449a-a85e-8c68d506776c"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-022-06)  / 45 g in 1 TUBE", "package_ndc": "21922-022-06", "marketing_start_date": "20210520"}], "brand_name": "CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE", "product_id": "21922-022_c3c0a548-d788-41fc-b2f8-99431a48cd05", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "21922-022", "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", "brand_name_suffix": "CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "50 mg/g"}, {"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}], "application_number": "ANDA212433", "marketing_category": "ANDA", "marketing_start_date": "20210520", "listing_expiration_date": "20261231"}