clopidogrel

Generic: clopidogrel bisulfate

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

Drug Facts

Product Profile

Brand Name clopidogrel
Generic Name clopidogrel bisulfate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clopidogrel bisulfate 75 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-357
Product ID 65862-357_ff58c1f3-4875-4d10-aca7-c622af163cef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090540
Listing Expiration 2026-12-31
Marketing Start 2012-05-17

Pharmacologic Class

Classes
cytochrome p450 2c8 inhibitors [moa] decreased platelet aggregation [pe] p2y12 platelet inhibitor [epc] p2y12 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862357
Hyphenated Format 65862-357

Supplemental Identifiers

RxCUI
309362
UPC
0365862357304
UNII
08I79HTP27

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 clopidogrel (source: ndc)
Generic Name clopidogrel bisulfate (source: ndc)
Application Number ANDA090540 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-357-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-357-05)
  • 10 BLISTER PACK in 1 CARTON (65862-357-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-357-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-357-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-357-99)
source: ndc

Packages (6)

65862-357-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-357-01) 65862-357-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-357-05) 65862-357-10 10 BLISTER PACK in 1 CARTON (65862-357-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-357-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-357-30) 65862-357-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-357-90) 65862-357-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-357-99)

Ingredients (1)

clopidogrel bisulfate (75 mg/1)

Linked Drug Pages (1)

Clopidogrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff58c1f3-4875-4d10-aca7-c622af163cef", "openfda": {"upc": ["0365862357304"], "unii": ["08I79HTP27"], "rxcui": ["309362"], "spl_set_id": ["0078fb3d-3595-4ae1-a059-1d5e81c879cf"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-357-01)", "package_ndc": "65862-357-01", "marketing_start_date": "20120517"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-357-05)", "package_ndc": "65862-357-05", "marketing_start_date": "20120517"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-357-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-357-10", "marketing_start_date": "20120517"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-357-30)", "package_ndc": "65862-357-30", "marketing_start_date": "20120517"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-357-90)", "package_ndc": "65862-357-90", "marketing_start_date": "20120517"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-357-99)", "package_ndc": "65862-357-99", "marketing_start_date": "20120517"}], "brand_name": "Clopidogrel", "product_id": "65862-357_ff58c1f3-4875-4d10-aca7-c622af163cef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "65862-357", "generic_name": "Clopidogrel Bisulfate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clopidogrel", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "75 mg/1"}], "application_number": "ANDA090540", "marketing_category": "ANDA", "marketing_start_date": "20120517", "listing_expiration_date": "20261231"}