ticagrelor

Generic: ticagrelor

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

Drug Facts

Product Profile

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

ticagrelor 90 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-115
Product ID 42658-115_2a4a4c5f-1eca-ad64-e063-6294a90a128b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208575
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Established (EPC)
p2y12 platelet inhibitor [epc]
Mechanism of Action
p2y12 receptor antagonists [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]
Physiologic Effect
decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658115
Hyphenated Format 42658-115

Supplemental Identifiers

RxCUI
1116635
UPC
0342658115072
UNII
GLH0314RVC
NUI
N0000182142 N0000008832 N0000182143 N0000182141 N0000185503

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 ticagrelor (source: ndc)
Generic Name ticagrelor (source: ndc)
Application Number ANDA208575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42658-115-07)
  • 180 TABLET, FILM COATED in 1 BOTTLE (42658-115-10)
source: ndc

Packages (3)

42658-115-03 60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) 42658-115-07 500 TABLET, FILM COATED in 1 BOTTLE (42658-115-07) 42658-115-10 180 TABLET, FILM COATED in 1 BOTTLE (42658-115-10)

Ingredients (1)

ticagrelor (90 mg/1)

Linked Drug Pages (1)

Ticagrelor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a4a4c5f-1eca-ad64-e063-6294a90a128b", "openfda": {"nui": ["N0000182142", "N0000008832", "N0000182143", "N0000182141", "N0000185503"], "upc": ["0342658115072"], "unii": ["GLH0314RVC"], "rxcui": ["1116635"], "spl_set_id": ["c4c1ca82-99bd-451a-ad77-7fe28c4ae3e8"], "pharm_class_pe": ["Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["P2Y12 Platelet Inhibitor [EPC]"], "pharm_class_moa": ["P2Y12 Receptor Antagonists [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03)", "package_ndc": "42658-115-03", "marketing_start_date": "20250101"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42658-115-07)", "package_ndc": "42658-115-07", "marketing_start_date": "20250101"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (42658-115-10)", "package_ndc": "42658-115-10", "marketing_start_date": "20250101"}], "brand_name": "Ticagrelor", "product_id": "42658-115_2a4a4c5f-1eca-ad64-e063-6294a90a128b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "P-Glycoprotein Inhibitors [MoA]", "P2Y12 Platelet Inhibitor [EPC]", "P2Y12 Receptor Antagonists [MoA]"], "product_ndc": "42658-115", "generic_name": "Ticagrelor", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ticagrelor", "active_ingredients": [{"name": "TICAGRELOR", "strength": "90 mg/1"}], "application_number": "ANDA208575", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}