clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

clindamycin hydrochloride 300 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-185
Product ID 50268-185_0e860109-7258-1c28-e063-6394a90a50ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207402
Listing Expiration 2026-12-31
Marketing Start 2020-10-27

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 50268185
Hyphenated Format 50268-185

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 ANDA207402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-185-15) / 1 CAPSULE in 1 BLISTER PACK (50268-185-11)
source: ndc

Packages (1)

50268-185-15 50 BLISTER PACK in 1 BOX (50268-185-15) / 1 CAPSULE in 1 BLISTER PACK (50268-185-11)

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": "0e860109-7258-1c28-e063-6394a90a50ef", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["284215"], "spl_set_id": ["b2a810f1-c009-e973-e053-2a95a90ad5b0"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-185-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-185-11)", "package_ndc": "50268-185-15", "marketing_start_date": "20201027"}], "brand_name": "CLINDAMYCIN HYDROCHLORIDE", "product_id": "50268-185_0e860109-7258-1c28-e063-6394a90a50ef", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "50268-185", "generic_name": "Clindamycin hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINDAMYCIN HYDROCHLORIDE", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207402", "marketing_category": "ANDA", "marketing_start_date": "20201027", "listing_expiration_date": "20261231"}