FDA.reportPublic FDA data

TICAGRELOR

Product NDC
72205-406
11-digit product format
722050406
Labeler code
72205
Product ID
72205-406_fb424a50-a319-4227-851f-2f59d236adf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TICAGRELOR
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208596
Marketing category
ANDA
Marketing start
2025-07-19
Substance
TICAGRELOR
Active strength
60 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TICAGRELOR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TICAGRELOR60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLH0314RVC
Rxcui1116635, 1666332

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
72205-406-01TICAGRELOR60 in 1 BOTTLETABLET603
72205-406-02TICAGRELOR1000 in 1 BOTTLETABLET10003
72205-406-04TICAGRELOR1 in 1 CARTONTABLET13
72205-406-04TICAGRELOR14 in 1 BLISTER PACKTABLET143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-406-01EA - Each72205-40637448110-b2c9-4fc0-898e-e6a46749b29d12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSNb1c29d47-960f-4fc4-b6ff-399e2c6eec4c3
1116635ticagrelor 90 MG Oral TabletPSNb1c29d47-960f-4fc4-b6ff-399e2c6eec4c3
1666332ticagrelor 60 MG Oral TabletSCDb1c29d47-960f-4fc4-b6ff-399e2c6eec4c3
1116635ticagrelor 90 MG Oral TabletSCDb1c29d47-960f-4fc4-b6ff-399e2c6eec4c3
1666332ticagrelor 60 MG Oral TabletPSNa50eb0b4-1bee-4781-8eba-75e324540d362
1116635ticagrelor 90 MG Oral TabletPSNa50eb0b4-1bee-4781-8eba-75e324540d362
1666332ticagrelor 60 MG Oral TabletSCDa50eb0b4-1bee-4781-8eba-75e324540d362
1116635ticagrelor 90 MG Oral TabletSCDa50eb0b4-1bee-4781-8eba-75e324540d362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-406-017220504060160 TABLET in 1 BOTTLE (72205-406-01) 60 tablet2025-07-19NoNoHistorical
72205-406-02722050406021000 TABLET in 1 BOTTLE (72205-406-02) 1000 tablet2025-07-19NoNoHistorical
72205-406-04722050406041 BLISTER PACK in 1 CARTON (72205-406-04) / 14 TABLET in 1 BLISTER PACK1 blister pack2025-07-19NoNoHistorical