clindamycin phosphate and benzoyl peroxide

Generic: clindamycin phosphate, benzoyl peroxide

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate and benzoyl peroxide
Generic Name clindamycin phosphate, benzoyl peroxide
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-597
Product ID 45802-597_fc3fe08e-5d69-42c0-bbdd-887ff1d944a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205397
Listing Expiration 2026-12-31
Marketing Start 2019-09-12

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 45802597
Hyphenated Format 45802-597

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, benzoyl peroxide (source: ndc)
Application Number ANDA205397 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (45802-597-01) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

45802-597-01 1 BOTTLE, PUMP in 1 CARTON (45802-597-01) / 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": "fc3fe08e-5d69-42c0-bbdd-887ff1d944a6", "openfda": {"unii": ["W9WZN9A0GM", "EH6D7113I8"], "spl_set_id": ["221de6a3-c1d7-4dcf-a47b-51edaa682c2a"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (45802-597-01)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "45802-597-01", "marketing_start_date": "20190912"}], "brand_name": "Clindamycin Phosphate and Benzoyl Peroxide", "product_id": "45802-597_fc3fe08e-5d69-42c0-bbdd-887ff1d944a6", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "45802-597", "generic_name": "Clindamycin Phosphate, Benzoyl Peroxide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "ANDA205397", "marketing_category": "ANDA", "marketing_start_date": "20190912", "listing_expiration_date": "20261231"}