clindamycin hydrochloride

Generic: clindamycin hydrochloride

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

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
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 80425-0416
Product ID 80425-0416_1d7633a0-d956-7990-e063-6294a90a5f2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207402
Listing Expiration 2026-12-31
Marketing Start 2024-07-16

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 804250416
Hyphenated Format 80425-0416

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
  • 21 CAPSULE in 1 BOTTLE (80425-0416-1)
  • 28 CAPSULE in 1 BOTTLE (80425-0416-2)
  • 30 CAPSULE in 1 BOTTLE (80425-0416-3)
source: ndc

Packages (3)

80425-0416-1 21 CAPSULE in 1 BOTTLE (80425-0416-1) 80425-0416-2 28 CAPSULE in 1 BOTTLE (80425-0416-2) 80425-0416-3 30 CAPSULE in 1 BOTTLE (80425-0416-3)

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": "1d7633a0-d956-7990-e063-6294a90a5f2d", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["284215"], "spl_set_id": ["1d760cb7-d166-6707-e063-6394a90a8850"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE (80425-0416-1)", "package_ndc": "80425-0416-1", "marketing_start_date": "20240716"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (80425-0416-2)", "package_ndc": "80425-0416-2", "marketing_start_date": "20240716"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0416-3)", "package_ndc": "80425-0416-3", "marketing_start_date": "20240716"}], "brand_name": "CLINDAMYCIN HYDROCHLORIDE", "product_id": "80425-0416_1d7633a0-d956-7990-e063-6294a90a5f2d", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "80425-0416", "generic_name": "Clindamycin hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20240716", "listing_expiration_date": "20261231"}