clopidogrel

Generic: clopidogrel

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

Drug Facts

Product Profile

Brand Name clopidogrel
Generic Name clopidogrel
Labeler polygen pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clopidogrel bisulfate 75 mg/1

Manufacturer
POLYGEN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 52605-082
Product ID 52605-082_9e3256b5-2032-4615-967d-449d49b09921
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213351
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

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 52605082
Hyphenated Format 52605-082

Supplemental Identifiers

RxCUI
309362 749196
UPC
0352605083057 0352605083132 0352605082104 0352605082135
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 (source: ndc)
Application Number ANDA213351 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10)
  • 30 TABLET in 1 BOTTLE (52605-082-13)
source: ndc

Packages (2)

52605-082-10 1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10) 52605-082-13 30 TABLET in 1 BOTTLE (52605-082-13)

Ingredients (1)

clopidogrel bisulfate (75 mg/1)

Linked Drug Pages (1)

clopidogrel, Clopidogrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e3256b5-2032-4615-967d-449d49b09921", "openfda": {"upc": ["0352605083057", "0352605083132", "0352605082104", "0352605082135"], "unii": ["08I79HTP27"], "rxcui": ["309362", "749196"], "spl_set_id": ["56b5d12b-b3fe-4de9-a5ef-80377c72d843"], "manufacturer_name": ["POLYGEN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10)", "package_ndc": "52605-082-10", "marketing_start_date": "20210301"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (52605-082-13)", "package_ndc": "52605-082-13", "marketing_start_date": "20210301"}], "brand_name": "clopidogrel", "product_id": "52605-082_9e3256b5-2032-4615-967d-449d49b09921", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "52605-082", "generic_name": "clopidogrel", "labeler_name": "POLYGEN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clopidogrel", "active_ingredients": [{"name": "CLOPIDOGREL BISULFATE", "strength": "75 mg/1"}], "application_number": "ANDA213351", "marketing_category": "ANDA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}