TICAGRELOR

Product NDC
43547-657
11-digit product format
435470657
Labeler code
43547
Product ID
43547-657_d51fdfca-5940-4b3c-bfa2-003b208b9309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA208599
Marketing category
ANDA
Marketing start
2025-04-01
Substance
TICAGRELOR
Active strength
90 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TICAGRELOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-657-06TICAGRELOR60 in 1 BOTTLETABLET, FILM COATED603
43547-657-18TICAGRELOR180 in 1 BOTTLETABLET, FILM COATED1803
43547-657-50TICAGRELOR500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-657TICAGRELOR TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]2Current NDC, 3 package rows20250402_5be5ef20-fc9f-4c3b-a482-83ffd8a3ab47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116635ticagrelor 90 MG Oral TabletPSN5be5ef20-fc9f-4c3b-a482-83ffd8a3ab473
1116635ticagrelor 90 MG Oral TabletSCD5be5ef20-fc9f-4c3b-a482-83ffd8a3ab473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43547-657-064354706570660 TABLET, FILM COATED in 1 BOTTLE (43547-657-06) 2025-04-01NoNoCurrent
43547-657-1843547065718180 TABLET, FILM COATED in 1 BOTTLE (43547-657-18) 2025-04-01NoNoCurrent
43547-657-5043547065750500 TABLET, FILM COATED in 1 BOTTLE (43547-657-50) 2025-04-01NoNoCurrent