clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-186
Product ID 65862-186_f87366fc-7b22-4528-a882-7622634d7ae5
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 65862186
Hyphenated Format 65862-186

Supplemental Identifiers

RxCUI
197518 284215
UNII
T20OQ1YN1W

Packaging Origin

Original Packager
true

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 CAPSULE in 1 BOTTLE (65862-186-01)
  • 500 CAPSULE in 1 BOTTLE (65862-186-05)
  • 16 CAPSULE in 1 BOTTLE (65862-186-16)
source: ndc

Packages (3)

65862-186-01 100 CAPSULE in 1 BOTTLE (65862-186-01) 65862-186-05 500 CAPSULE in 1 BOTTLE (65862-186-05) 65862-186-16 16 CAPSULE in 1 BOTTLE (65862-186-16)

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": "f87366fc-7b22-4528-a882-7622634d7ae5", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["197518", "284215"], "spl_set_id": ["2367340c-d297-4a3f-8253-6d27a0ed39cb"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65862-186-01)", "package_ndc": "65862-186-01", "marketing_start_date": "20090826"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-186-05)", "package_ndc": "65862-186-05", "marketing_start_date": "20090826"}, {"sample": false, "description": "16 CAPSULE in 1 BOTTLE (65862-186-16)", "package_ndc": "65862-186-16", "marketing_start_date": "20090826"}], "brand_name": "Clindamycin Hydrochloride", "product_id": "65862-186_f87366fc-7b22-4528-a882-7622634d7ae5", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "65862-186", "generic_name": "Clindamycin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "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"}