clindamycin phosphate

Generic: clindamycin phosphate topical

Labeler: i3 pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate
Generic Name clindamycin phosphate topical
Labeler i3 pharmaceuticals, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
i3 Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72319-696
Product ID 72319-696_389362be-d31f-f00c-e063-6294a90a61b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065513
Listing Expiration 2026-12-31
Marketing Start 2025-06-16

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 72319696
Hyphenated Format 72319-696

Supplemental Identifiers

RxCUI
797274
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 topical (source: ndc)
Application Number ANDA065513 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 60 APPLICATOR in 1 JAR (72319-696-60) / 1 mL in 1 APPLICATOR
source: ndc

Packages (1)

72319-696-60 60 APPLICATOR in 1 JAR (72319-696-60) / 1 mL in 1 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": "389362be-d31f-f00c-e063-6294a90a61b6", "openfda": {"unii": ["EH6D7113I8"], "rxcui": ["797274"], "spl_set_id": ["8233eca5-d8bb-448d-9696-cb680da7a24f"], "manufacturer_name": ["i3 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 APPLICATOR in 1 JAR (72319-696-60)  / 1 mL in 1 APPLICATOR", "package_ndc": "72319-696-60", "marketing_start_date": "20250616"}], "brand_name": "Clindamycin phosphate", "product_id": "72319-696_389362be-d31f-f00c-e063-6294a90a61b6", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "72319-696", "generic_name": "Clindamycin phosphate topical", "labeler_name": "i3 Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA065513", "marketing_category": "ANDA", "marketing_start_date": "20250616", "listing_expiration_date": "20261231"}