clindamycin hcl

Generic: clindamycin hcl

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hcl
Generic Name clindamycin hcl
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0103
Product ID 80425-0103_2a99aae5-c901-7940-e063-6294a90a4146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065061
Listing Expiration 2026-12-31
Marketing Start 2001-03-23

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 804250103
Hyphenated Format 80425-0103

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 hcl (source: ndc)
Generic Name clindamycin hcl (source: ndc)
Application Number ANDA065061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0103-1)
source: ndc

Packages (1)

80425-0103-1 30 CAPSULE in 1 BOTTLE (80425-0103-1)

Ingredients (1)

clindamycin hydrochloride (300 mg/1)

Linked Drug Pages (1)

Clindamycin HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99aae5-c901-7940-e063-6294a90a4146", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["284215"], "spl_set_id": ["b43dc396-17ef-a523-e053-2a95a90ac872"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0103-1)", "package_ndc": "80425-0103-1", "marketing_start_date": "20010323"}], "brand_name": "Clindamycin HCL", "product_id": "80425-0103_2a99aae5-c901-7940-e063-6294a90a4146", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "80425-0103", "generic_name": "Clindamycin HCL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin HCL", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA065061", "marketing_category": "ANDA", "marketing_start_date": "20010323", "listing_expiration_date": "20261231"}