clindamycin phosphate

Generic: clindamycin phosphate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phosphate
Generic Name clindamycin phosphate
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-478
Product ID 62135-478_3e0d9a3b-5c3d-e0b5-e063-6394a90a2980
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209846
Listing Expiration 2026-12-31
Marketing Start 2018-02-08

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 62135478
Hyphenated Format 62135-478

Supplemental Identifiers

RxCUI
309333
UPC
0362135478605
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 ANDA209846 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-30)
  • 60 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-60)
source: ndc

Packages (2)

62135-478-30 30 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-30) 62135-478-60 60 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-60)

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": "3e0d9a3b-5c3d-e0b5-e063-6394a90a2980", "openfda": {"upc": ["0362135478605"], "unii": ["EH6D7113I8"], "rxcui": ["309333"], "spl_set_id": ["7740ed35-ff93-4c5e-8983-934ff7b86da7"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-30)", "package_ndc": "62135-478-30", "marketing_start_date": "20250828"}, {"sample": false, "description": "60 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-60)", "package_ndc": "62135-478-60", "marketing_start_date": "20250828"}], "brand_name": "Clindamycin Phosphate", "product_id": "62135-478_3e0d9a3b-5c3d-e0b5-e063-6394a90a2980", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "62135-478", "generic_name": "Clindamycin Phosphate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA209846", "marketing_category": "ANDA", "marketing_start_date": "20180208", "listing_expiration_date": "20261231"}