ticagrelor

Generic: ticagrelor

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

Drug Facts

Product Profile

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

ticagrelor 60 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2214
Product ID 0378-2214_fc333c4a-ad63-4d67-a3f7-431ac469d116
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208597
Listing Expiration 2026-12-31
Marketing Start 2025-09-25

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 03782214
Hyphenated Format 0378-2214

Supplemental Identifiers

RxCUI
1116635 1666332
UPC
0303782215915
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 ANDA208597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91)
source: ndc

Packages (1)

0378-2214-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91)

Ingredients (1)

ticagrelor (60 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": "fc333c4a-ad63-4d67-a3f7-431ac469d116", "openfda": {"nui": ["N0000182142", "N0000008832", "N0000182143", "N0000182141", "N0000185503"], "upc": ["0303782215915"], "unii": ["GLH0314RVC"], "rxcui": ["1116635", "1666332"], "spl_set_id": ["fc333c4a-ad63-4d67-a3f7-431ac469d116"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91)", "package_ndc": "0378-2214-91", "marketing_start_date": "20250925"}], "brand_name": "Ticagrelor", "product_id": "0378-2214_fc333c4a-ad63-4d67-a3f7-431ac469d116", "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": "0378-2214", "generic_name": "Ticagrelor", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ticagrelor", "active_ingredients": [{"name": "TICAGRELOR", "strength": "60 mg/1"}], "application_number": "ANDA208597", "marketing_category": "ANDA", "marketing_start_date": "20250925", "listing_expiration_date": "20261231"}