clindamycin phosphate and benzoyl peroxide

Generic: clindamycin phosphate and benzoyl peroxide

Labeler: actavis pharma, 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 actavis pharma, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3916
Product ID 0591-3916_c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205128
Marketing Start 2019-02-19
Marketing End 2026-06-30

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 05913916
Hyphenated Format 0591-3916

Supplemental Identifiers

RxCUI
885131
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 ANDA205128 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (0591-3916-68) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

0591-3916-68 1 BOTTLE, PUMP in 1 CARTON (0591-3916-68) / 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": "c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0", "openfda": {"unii": ["W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["885131"], "spl_set_id": ["87622142-000b-460b-977e-92d6735f5337"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0591-3916-68)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "0591-3916-68", "marketing_end_date": "20260630", "marketing_start_date": "20190219"}], "brand_name": "Clindamycin phosphate and benzoyl peroxide", "product_id": "0591-3916_c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0591-3916", "generic_name": "Clindamycin phosphate and benzoyl peroxide", "labeler_name": "Actavis Pharma, 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": "ANDA205128", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20190219"}