clopidogrel

Generic: clopidogrel bisulfate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

clopidogrel bisulfate 300 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-184
Product ID 50268-184_486110ba-88b3-80cc-e063-6294a90a28b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204165
Listing Expiration 2027-12-31
Marketing Start 2019-10-11

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 50268184
Hyphenated Format 50268-184

Supplemental Identifiers

RxCUI
749196
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 ANDA204165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-184-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-184-11)
source: ndc

Packages (1)

50268-184-12 20 BLISTER PACK in 1 BOX (50268-184-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-184-11)

Ingredients (1)

clopidogrel bisulfate (300 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": "486110ba-88b3-80cc-e063-6294a90a28b8", "openfda": {"unii": ["08I79HTP27"], "rxcui": ["749196"], "spl_set_id": ["94a5cdc4-e063-1d46-e053-2995a90a7e15"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-184-12)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-184-11)", "package_ndc": "50268-184-12", "marketing_start_date": "20191011"}], "brand_name": "Clopidogrel", "product_id": "50268-184_486110ba-88b3-80cc-e063-6294a90a28b8", "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": "50268-184", "generic_name": "Clopidogrel Bisulfate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clopidogrel", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "300 mg/1"}], "application_number": "ANDA204165", "marketing_category": "ANDA", "marketing_start_date": "20191011", "listing_expiration_date": "20271231"}