clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7194
Product ID 0904-7194_3d17632f-136b-4ad5-b440-5e7f9989a51f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065442
Listing Expiration 2026-12-31
Marketing Start 2009-08-26

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 09047194
Hyphenated Format 0904-7194

Supplemental Identifiers

RxCUI
284215
UNII
T20OQ1YN1W

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 ANDA065442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7194-61 100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK

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": "3d17632f-136b-4ad5-b440-5e7f9989a51f", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["284215"], "spl_set_id": ["d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7194-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7194-61", "marketing_start_date": "20090826"}], "brand_name": "Clindamycin Hydrochloride", "product_id": "0904-7194_3d17632f-136b-4ad5-b440-5e7f9989a51f", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0904-7194", "generic_name": "Clindamycin Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin Hydrochloride", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA065442", "marketing_category": "ANDA", "marketing_start_date": "20090826", "listing_expiration_date": "20261231"}