clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-614
Product ID 76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207402
Listing Expiration 2026-12-31
Marketing Start 2019-01-07

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 76420614
Hyphenated Format 76420-614

Supplemental Identifiers

RxCUI
197518 284215 309329
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
  • 100 CAPSULE in 1 BOTTLE (76420-614-01)
  • 12 CAPSULE in 1 BOTTLE (76420-614-12)
  • 20 CAPSULE in 1 BOTTLE (76420-614-20)
  • 21 CAPSULE in 1 BOTTLE (76420-614-21)
  • 30 CAPSULE in 1 BOTTLE (76420-614-30)
  • 60 CAPSULE in 1 BOTTLE (76420-614-60)
  • 90 CAPSULE in 1 BOTTLE (76420-614-90)
source: ndc

Packages (7)

76420-614-01 100 CAPSULE in 1 BOTTLE (76420-614-01) 76420-614-12 12 CAPSULE in 1 BOTTLE (76420-614-12) 76420-614-20 20 CAPSULE in 1 BOTTLE (76420-614-20) 76420-614-21 21 CAPSULE in 1 BOTTLE (76420-614-21) 76420-614-30 30 CAPSULE in 1 BOTTLE (76420-614-30) 76420-614-60 60 CAPSULE in 1 BOTTLE (76420-614-60) 76420-614-90 90 CAPSULE in 1 BOTTLE (76420-614-90)

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": "054ad3e6-3c9c-e6d2-e063-6294a90ab46f", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["197518", "284215", "309329"], "spl_set_id": ["7d3e6ec5-93e9-4ce0-8276-b19aa97eb772"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-614-01)", "package_ndc": "76420-614-01", "marketing_start_date": "20230914"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE (76420-614-12)", "package_ndc": "76420-614-12", "marketing_start_date": "20230914"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-614-20)", "package_ndc": "76420-614-20", "marketing_start_date": "20230914"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (76420-614-21)", "package_ndc": "76420-614-21", "marketing_start_date": "20230914"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-614-30)", "package_ndc": "76420-614-30", "marketing_start_date": "20230914"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-614-60)", "package_ndc": "76420-614-60", "marketing_start_date": "20230914"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-614-90)", "package_ndc": "76420-614-90", "marketing_start_date": "20230914"}], "brand_name": "CLINDAMYCIN HYDROCHLORIDE", "product_id": "76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "76420-614", "generic_name": "Clindamycin hydrochloride", "labeler_name": "Asclemed USA, Inc.", "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": "20190107", "listing_expiration_date": "20261231"}