clindamycin phosphate

Generic: clindamycin phosphate

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate
Generic Name clindamycin phosphate
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clindamycin phosphate 20 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0277
Product ID 0168-0277_6831719c-6e74-41d9-ab44-225fa088e3a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065139
Listing Expiration 2027-12-31
Marketing Start 2004-12-27

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 01680277
Hyphenated Format 0168-0277

Supplemental Identifiers

RxCUI
309337
UPC
0301680277400
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 clindamycin phosphate (source: ndc)
Generic Name clindamycin phosphate (source: ndc)
Application Number ANDA065139 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)
source: ndc

Packages (1)

0168-0277-40 40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)

Ingredients (1)

clindamycin phosphate (20 mg/g)

Linked Drug Pages (1)

Clindamycin Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "6831719c-6e74-41d9-ab44-225fa088e3a6", "openfda": {"upc": ["0301680277400"], "unii": ["EH6D7113I8"], "rxcui": ["309337"], "spl_set_id": ["997a23c8-f0d7-49d5-af33-e11f2ddab3c7"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40)", "package_ndc": "0168-0277-40", "marketing_start_date": "20041227"}], "brand_name": "Clindamycin Phosphate", "product_id": "0168-0277_6831719c-6e74-41d9-ab44-225fa088e3a6", "dosage_form": "CREAM", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0168-0277", "generic_name": "clindamycin phosphate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "20 mg/g"}], "application_number": "ANDA065139", "marketing_category": "ANDA", "marketing_start_date": "20041227", "listing_expiration_date": "20271231"}