clindamycin phosphate

Generic: clindamycin phosphate gel usp, 1%

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

Drug Facts

Product Profile

Brand Name clindamycin phosphate
Generic Name clindamycin phosphate gel usp, 1%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

clindamycin phosphate 10 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-027
Product ID 21922-027_5de916eb-6efb-47e7-b589-4a082694f392
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212438
Listing Expiration 2026-12-31
Marketing Start 2021-03-15

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 21922027
Hyphenated Format 21922-027

Supplemental Identifiers

RxCUI
2676585
UPC
0321922027075 0321922027051
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 gel usp, 1% (source: ndc)
Application Number ANDA212438 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-027-05) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-027-07) / 60 g in 1 TUBE
source: ndc

Packages (2)

21922-027-05 1 TUBE in 1 CARTON (21922-027-05) / 30 g in 1 TUBE 21922-027-07 1 TUBE in 1 CARTON (21922-027-07) / 60 g in 1 TUBE

Ingredients (1)

clindamycin phosphate (10 mg/g)

Linked Drug Pages (1)

Clindamycin Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "5de916eb-6efb-47e7-b589-4a082694f392", "openfda": {"upc": ["0321922027075", "0321922027051"], "unii": ["EH6D7113I8"], "rxcui": ["2676585"], "spl_set_id": ["ac21d7ad-f94e-4d57-95e3-1648add7ad0b"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-027-05)  / 30 g in 1 TUBE", "package_ndc": "21922-027-05", "marketing_start_date": "20210315"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-027-07)  / 60 g in 1 TUBE", "package_ndc": "21922-027-07", "marketing_start_date": "20210315"}], "brand_name": "Clindamycin Phosphate", "product_id": "21922-027_5de916eb-6efb-47e7-b589-4a082694f392", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "21922-027", "generic_name": "Clindamycin Phosphate Gel USP, 1%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Phosphate", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}], "application_number": "ANDA212438", "marketing_category": "ANDA", "marketing_start_date": "20210315", "listing_expiration_date": "20261231"}