clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2121
Product ID 69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065194
Listing Expiration 2026-12-31
Marketing Start 2022-04-25

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 692382121
Hyphenated Format 69238-2121

Supplemental Identifiers

RxCUI
284215
UPC
0369238212136
UNII
T20OQ1YN1W

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 hydrochloride (source: ndc)
Generic Name clindamycin hydrochloride (source: ndc)
Application Number ANDA065194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)
source: ndc

Packages (1)

69238-2121-3 3 BLISTER PACK in 1 CARTON (69238-2121-3) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)

Ingredients (1)

clindamycin hydrochloride (300 mg/1)

Linked Drug Pages (1)

clindamycin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f118e287-5acc-4a8b-bcf0-01436de5bdf9", "openfda": {"upc": ["0369238212136"], "unii": ["T20OQ1YN1W"], "rxcui": ["284215"], "spl_set_id": ["e08eea9e-464c-429e-9584-b768f5127767"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (69238-2121-3)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69238-2121-4)", "package_ndc": "69238-2121-3", "marketing_start_date": "20220425"}], "brand_name": "clindamycin hydrochloride", "product_id": "69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "69238-2121", "generic_name": "clindamycin hydrochloride", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clindamycin hydrochloride", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA065194", "marketing_category": "ANDA", "marketing_start_date": "20220425", "listing_expiration_date": "20261231"}