clindamycin phosphate

Generic: clindamycin phosphate

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
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 inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0201
Product ID 0168-0201_30743ed0-409c-4fec-bdd5-d113ef8ec838
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064159
Listing Expiration 2026-12-31
Marketing Start 1997-06-05

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 01680201
Hyphenated Format 0168-0201

Supplemental Identifiers

RxCUI
197519 309333 2676585
UPC
0301680203607 0301680201603 0301680202303
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 ANDA064159 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

0168-0201-30 1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLE 0168-0201-60 1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLE

Ingredients (1)

clindamycin phosphate (10 mg/mL)

Linked Drug Pages (1)

clindamycin phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "30743ed0-409c-4fec-bdd5-d113ef8ec838", "openfda": {"upc": ["0301680203607", "0301680201603", "0301680202303"], "unii": ["EH6D7113I8"], "rxcui": ["197519", "309333", "2676585"], "spl_set_id": ["62a2019f-7410-4251-95ed-181925ade6e4"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0168-0201-30)  / 30 mL in 1 BOTTLE", "package_ndc": "0168-0201-30", "marketing_start_date": "19970605"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0168-0201-60)  / 60 mL in 1 BOTTLE", "package_ndc": "0168-0201-60", "marketing_start_date": "19970605"}], "brand_name": "clindamycin phosphate", "product_id": "0168-0201_30743ed0-409c-4fec-bdd5-d113ef8ec838", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0168-0201", "generic_name": "clindamycin phosphate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clindamycin phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA064159", "marketing_category": "ANDA", "marketing_start_date": "19970605", "listing_expiration_date": "20261231"}