clopidogrel

Generic: clopidogrel bisulfate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clopidogrel
Generic Name clopidogrel bisulfate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clopidogrel bisulfate 75 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-527
Product ID 71610-527_5364ce21-e700-4cce-bd59-aadec2a56428
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076274
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 71610527
Hyphenated Format 71610-527

Supplemental Identifiers

RxCUI
309362
UNII
08I79HTP27

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 ANDA076274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-527-60)
source: ndc

Packages (1)

71610-527-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-527-60)

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": "5364ce21-e700-4cce-bd59-aadec2a56428", "openfda": {"unii": ["08I79HTP27"], "rxcui": ["309362"], "spl_set_id": ["d49362ae-f78a-47d8-ac14-8262d621fcaa"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-527-60)", "package_ndc": "71610-527-60", "marketing_start_date": "20210212"}], "brand_name": "Clopidogrel", "product_id": "71610-527_5364ce21-e700-4cce-bd59-aadec2a56428", "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": "71610-527", "generic_name": "clopidogrel bisulfate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clopidogrel", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "75 mg/1"}], "application_number": "ANDA076274", "marketing_category": "ANDA", "marketing_start_date": "20120517", "listing_expiration_date": "20261231"}