clindamycin phosphate

Generic: clindamycin phosphate

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

Drug Facts

Product Profile

Brand Name clindamycin phosphate
Generic Name clindamycin phosphate
Labeler padagis israel pharmaceuticals ltd
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-562
Product ID 45802-562_c7eefa68-8d95-41e9-b789-72d14ee74ff8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064050
Listing Expiration 2027-12-31
Marketing Start 2013-09-17

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 45802562
Hyphenated Format 45802-562

Supplemental Identifiers

RxCUI
309333
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 ANDA064050 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02) / 60 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (2)

45802-562-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR 45802-562-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02) / 60 mL in 1 BOTTLE, WITH APPLICATOR

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": "c7eefa68-8d95-41e9-b789-72d14ee74ff8", "openfda": {"unii": ["EH6D7113I8"], "rxcui": ["309333"], "spl_set_id": ["461ab478-3cf6-4e9b-ba7d-0331b379cacf"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01)  / 30 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "45802-562-01", "marketing_start_date": "20130917"}, {"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02)  / 60 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "45802-562-02", "marketing_start_date": "20130917"}], "brand_name": "Clindamycin Phosphate", "product_id": "45802-562_c7eefa68-8d95-41e9-b789-72d14ee74ff8", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "45802-562", "generic_name": "Clindamycin Phosphate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA064050", "marketing_category": "ANDA", "marketing_start_date": "20130917", "listing_expiration_date": "20271231"}