clindamycin and benzoyl peroxide (68462-859)

Drug Facts

Product Profile

Brand Name clindamycin and benzoyl peroxide

Generic Name clindamycin and benzoyl peroxide

Labeler glenmark pharmaceuticals inc., usa

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

benzoyl peroxide 50 mg/g, clindamycin phosphate 10 mg/g

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-859

Product ID 68462-859_03e34592-8f1e-49cd-8a20-824d2b18b4b5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209252

Listing Expiration 2027-12-31

Marketing Start 2021-09-24

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 68462859

Hyphenated Format 68462-859

Supplemental Identifiers

RxCUI

358917

UPC

0368462859247 0368462857861 0368462484692 0368462484869 0368462484982

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 and benzoyl peroxide (source: ndc)

Generic Name clindamycin and benzoyl peroxide (source: ndc)

Application Number ANDA209252 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

50 mg/g
10 mg/g

source: ndc

Packaging

1 BOTTLE, PUMP in 1 CARTON (68462-859-24) / 35 g in 1 BOTTLE, PUMP
1 BOTTLE, PUMP in 1 CARTON (68462-859-27) / 50 g in 1 BOTTLE, PUMP

source: ndc

Packages (2)

68462-859-24 1 BOTTLE, PUMP in 1 CARTON (68462-859-24) / 35 g in 1 BOTTLE, PUMP 68462-859-27 1 BOTTLE, PUMP in 1 CARTON (68462-859-27) / 50 g in 1 BOTTLE, PUMP

Ingredients (2)

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

Linked Drug Pages (1)

clindamycin and benzoyl peroxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "03e34592-8f1e-49cd-8a20-824d2b18b4b5", "openfda": {"upc": ["0368462859247", "0368462857861", "0368462484692", "0368462484869", "0368462484982"], "unii": ["W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["358917"], "spl_set_id": ["76795d1b-e1f2-4d1d-b42a-f1d4448c63c0"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68462-859-24)  / 35 g in 1 BOTTLE, PUMP", "package_ndc": "68462-859-24", "marketing_start_date": "20210924"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68462-859-27)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "68462-859-27", "marketing_start_date": "20210924"}], "brand_name": "clindamycin and benzoyl peroxide", "product_id": "68462-859_03e34592-8f1e-49cd-8a20-824d2b18b4b5", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "68462-859", "generic_name": "clindamycin and benzoyl peroxide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clindamycin and benzoyl peroxide", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "50 mg/g"}, {"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}], "application_number": "ANDA209252", "marketing_category": "ANDA", "marketing_start_date": "20210924", "listing_expiration_date": "20271231"}