clindamycin phoaphate topical solution usp, 1%

Generic: clindamycin phosphate topical solution usp, 1%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin phoaphate topical solution usp, 1%
Generic Name clindamycin phosphate topical solution usp, 1%
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-002
Product ID 21922-002_0babc3d6-8dfa-4034-8811-24af75b21048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209914
Listing Expiration 2026-12-31
Marketing Start 2019-03-04

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 21922002
Hyphenated Format 21922-002

Supplemental Identifiers

RxCUI
309333
UPC
0321922002218 0321922002010
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 phoaphate topical solution usp, 1% (source: ndc)
Generic Name clindamycin phosphate topical solution usp, 1% (source: ndc)
Application Number ANDA209914 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE
source: ndc

Packages (2)

21922-002-01 1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE 21922-002-21 1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE

Ingredients (1)

clindamycin phosphate (10 mg/mL)

Linked Drug Pages (1)

Clindamycin Phoaphate Topical Solution USP, 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0babc3d6-8dfa-4034-8811-24af75b21048", "openfda": {"upc": ["0321922002218", "0321922002010"], "unii": ["EH6D7113I8"], "rxcui": ["309333"], "spl_set_id": ["b2dfb76b-db09-43e7-8366-6791449a4918"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-002-01)  / 60 mL in 1 BOTTLE", "package_ndc": "21922-002-01", "marketing_start_date": "20190304"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-002-21)  / 30 mL in 1 BOTTLE", "package_ndc": "21922-002-21", "marketing_start_date": "20200713"}], "brand_name": "Clindamycin Phoaphate Topical Solution USP, 1%", "product_id": "21922-002_0babc3d6-8dfa-4034-8811-24af75b21048", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "21922-002", "generic_name": "Clindamycin Phosphate Topical Solution USP, 1%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phoaphate Topical Solution USP, 1%", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/mL"}], "application_number": "ANDA209914", "marketing_category": "ANDA", "marketing_start_date": "20190304", "listing_expiration_date": "20261231"}