clindamycin phosphate and benzoyl peroxide

Generic: clindamycin phosphate and benzoyl peroxide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate and benzoyl peroxide
Generic Name clindamycin phosphate and benzoyl peroxide
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1367
Product ID 51672-1367_390b7e1e-a389-c3e6-e063-6394a90aa3aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206575
Listing Expiration 2026-12-31
Marketing Start 2019-08-19

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 516721367
Hyphenated Format 51672-1367

Supplemental Identifiers

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 ANDA206575 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1367-3) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

51672-1367-3 1 BOTTLE, PUMP in 1 CARTON (51672-1367-3) / 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": "390b7e1e-a389-c3e6-e063-6394a90aa3aa", "openfda": {"unii": ["W9WZN9A0GM", "EH6D7113I8"], "spl_set_id": ["0a98fc1e-be75-4c22-a7a7-2e4f033b3701"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1367-3)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1367-3", "marketing_start_date": "20190819"}], "brand_name": "Clindamycin Phosphate and Benzoyl Peroxide", "product_id": "51672-1367_390b7e1e-a389-c3e6-e063-6394a90aa3aa", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "51672-1367", "generic_name": "Clindamycin Phosphate and Benzoyl Peroxide", "labeler_name": "Sun Pharmaceutical Industries, 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": "ANDA206575", "marketing_category": "ANDA", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}