clopidogrel bisulfate

Generic: clopidogrel bisulfate

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

clopidogrel bisulfate 75 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-124
Product ID 50228-124_0789c766-42ac-6467-e063-6294a90a2c6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204165
Listing Expiration 2026-12-31
Marketing Start 2015-09-15

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 50228124
Hyphenated Format 50228-124

Supplemental Identifiers

RxCUI
309362 749196
UPC
0350228121057 0350228121309 0350228124058 0350228124904 0350228124102 0350228124300
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 ANDA204165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (50228-124-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-124-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-124-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90)
source: ndc

Packages (4)

50228-124-05 500 TABLET, FILM COATED in 1 BOTTLE (50228-124-05) 50228-124-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-124-10) 50228-124-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-124-30) 50228-124-90 90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90)

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": "0789c766-42ac-6467-e063-6294a90a2c6a", "openfda": {"upc": ["0350228121057", "0350228121309", "0350228124058", "0350228124904", "0350228124102", "0350228124300"], "unii": ["08I79HTP27"], "rxcui": ["309362", "749196"], "spl_set_id": ["d03cfc18-c9e4-41f8-b54d-6a7564c32afb"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (50228-124-05)", "package_ndc": "50228-124-05", "marketing_start_date": "20150915"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-124-10)", "package_ndc": "50228-124-10", "marketing_start_date": "20150915"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-124-30)", "package_ndc": "50228-124-30", "marketing_start_date": "20150915"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90)", "package_ndc": "50228-124-90", "marketing_start_date": "20150915"}], "brand_name": "Clopidogrel bisulfate", "product_id": "50228-124_0789c766-42ac-6467-e063-6294a90a2c6a", "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": "50228-124", "generic_name": "Clopidogrel bisulfate", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clopidogrel bisulfate", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "75 mg/1"}], "application_number": "ANDA204165", "marketing_category": "ANDA", "marketing_start_date": "20150915", "listing_expiration_date": "20261231"}