dipyridamole

Generic: dipyridamole

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

Drug Facts

Product Profile

Brand Name dipyridamole
Generic Name dipyridamole
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dipyridamole 75 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-189
Product ID 68382-189_8b638b19-214a-4a58-a336-656d690130e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040874
Listing Expiration 2026-12-31
Marketing Start 2008-05-22

Pharmacologic Class

Established (EPC)
platelet aggregation inhibitor [epc]
Physiologic Effect
decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382189
Hyphenated Format 68382-189

Supplemental Identifiers

RxCUI
197622 309952 309955
UNII
64ALC7F90C
NUI
N0000008832 N0000175578

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 dipyridamole (source: ndc)
Generic Name dipyridamole (source: ndc)
Application Number ANDA040874 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10)
  • 10 BLISTER PACK in 1 CARTON (68382-189-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

68382-189-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01) 68382-189-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05) 68382-189-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10) 68382-189-77 10 BLISTER PACK in 1 CARTON (68382-189-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

dipyridamole (75 mg/1)

Linked Drug Pages (1)

Dipyridamole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8b638b19-214a-4a58-a336-656d690130e3", "openfda": {"nui": ["N0000008832", "N0000175578"], "unii": ["64ALC7F90C"], "rxcui": ["197622", "309952", "309955"], "spl_set_id": ["004bada0-dbf7-4a94-8792-6833d7eeda2b"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Platelet Aggregation Inhibitor [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01)", "package_ndc": "68382-189-01", "marketing_start_date": "20080522"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05)", "package_ndc": "68382-189-05", "marketing_start_date": "20080522"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10)", "package_ndc": "68382-189-10", "marketing_start_date": "20080522"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-189-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68382-189-77", "marketing_start_date": "20080522"}], "brand_name": "Dipyridamole", "product_id": "68382-189_8b638b19-214a-4a58-a336-656d690130e3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "68382-189", "generic_name": "Dipyridamole", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dipyridamole", "active_ingredients": [{"name": "DIPYRIDAMOLE", "strength": "75 mg/1"}], "application_number": "ANDA040874", "marketing_category": "ANDA", "marketing_start_date": "20080522", "listing_expiration_date": "20261231"}