clindagel

Generic: clindamycin

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindagel
Generic Name clindamycin
Labeler bausch health us, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 16781-462
Product ID 16781-462_cb49818a-19bc-4bcc-8696-a8b749fefbe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050782
Listing Expiration 2026-12-31
Marketing Start 2013-11-25

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 16781462
Hyphenated Format 16781-462

Supplemental Identifiers

RxCUI
309332 351330
UNII
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 clindagel (source: ndc)
Generic Name clindamycin (source: ndc)
Application Number NDA050782 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE
source: ndc

Packages (2)

16781-462-06 6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE 16781-462-75 1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE

Ingredients (1)

clindamycin phosphate (10 mg/mL)

Linked Drug Pages (1)

Clindagel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "cb49818a-19bc-4bcc-8696-a8b749fefbe4", "openfda": {"unii": ["EH6D7113I8"], "rxcui": ["309332", "351330"], "spl_set_id": ["f7b4e985-719a-4547-b624-94612d520991"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "6 BOTTLE in 1 CARTON (16781-462-06)  / 7.3 mL in 1 BOTTLE", "package_ndc": "16781-462-06", "marketing_start_date": "20150701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (16781-462-75)  / 75 mL in 1 BOTTLE", "package_ndc": "16781-462-75", "marketing_start_date": "20131125"}], "brand_name": "Clindagel", "product_id": "16781-462_cb49818a-19bc-4bcc-8696-a8b749fefbe4", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "16781-462", "generic_name": "CLINDAMYCIN", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindagel", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "NDA050782", "marketing_category": "NDA", "marketing_start_date": "20131125", "listing_expiration_date": "20261231"}