clopidogrel bisulfate

Generic: clopidogrel bisulfate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clopidogrel bisulfate
Generic Name clopidogrel bisulfate
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

clopidogrel bisulfate 75 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-021
Product ID 82009-021_e8fadba0-80b2-f6fd-ba68-512d796e5d89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076273
Marketing Start 2022-11-15
Marketing End 2027-02-28

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 82009021
Hyphenated Format 82009-021

Supplemental Identifiers

RxCUI
309362
UPC
0382009021904
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 bisulfate (source: ndc)
Generic Name clopidogrel bisulfate (source: ndc)
Application Number ANDA076273 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82009-021-90)
source: ndc

Packages (2)

82009-021-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05) 82009-021-90 90 TABLET, FILM COATED in 1 BOTTLE (82009-021-90)

Ingredients (1)

clopidogrel bisulfate (75 mg/1)

Linked Drug Pages (1)

Clopidogrel bisulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e8fadba0-80b2-f6fd-ba68-512d796e5d89", "openfda": {"upc": ["0382009021904"], "unii": ["08I79HTP27"], "rxcui": ["309362"], "spl_set_id": ["333c7992-d481-b7d4-404f-9a49c85b6331"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05)", "package_ndc": "82009-021-05", "marketing_end_date": "20270228", "marketing_start_date": "20221115"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82009-021-90)", "package_ndc": "82009-021-90", "marketing_end_date": "20260331", "marketing_start_date": "20221115"}], "brand_name": "Clopidogrel bisulfate", "product_id": "82009-021_e8fadba0-80b2-f6fd-ba68-512d796e5d89", "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": "82009-021", "generic_name": "Clopidogrel bisulfate", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clopidogrel bisulfate", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "75 mg/1"}], "application_number": "ANDA076273", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20221115"}