FDA.reportPublic FDA data

TICAGRELOR

Product NDC
72205-368
11-digit product format
722050368
Labeler code
72205
Product ID
72205-368_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
2020-04-07
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
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
TICAGRELOR90 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
72205-368-11TICAGRELOR10 in 1 BLISTER PACKTABLET103
72205-368-11TICAGRELOR10 in 1 BOX, UNIT-DOSETABLET103
72205-368-18TICAGRELOR180 in 1 BOTTLETABLET1803
72205-368-60TICAGRELOR60 in 1 BOTTLETABLET603
72205-368-91TICAGRELOR100 in 1 BOTTLETABLET1003
72205-368-99TICAGRELOR1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-368-60EA - Each72205-368de38dc09-550f-4e07-a392-19e3aec5f98412025-05-14
72205-368-91EA - Each72205-368aff55721-3e08-4e40-b5b7-52e6acb431e312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-368TICAGRELOR TABLET [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 6 package rows20250419_b1c29d47-960f-4fc4-b6ff-399e2c6eec4c.zip

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
72205-368-117220503681110 BLISTER PACK in 1 BOX, UNIT-DOSE (72205-368-11) / 10 TABLET in 1 BLISTER PACK10 blister pack2025-05-01NoNoHistorical
72205-368-1872205036818180 TABLET in 1 BOTTLE (72205-368-18) 180 tablet2025-05-01NoNoHistorical
72205-368-607220503686060 TABLET in 1 BOTTLE (72205-368-60) 60 tablet2025-05-01NoNoHistorical
72205-368-9172205036891100 TABLET in 1 BOTTLE (72205-368-91) 100 tablet2025-05-01NoNoHistorical
72205-368-99722050368991000 TABLET in 1 BOTTLE (72205-368-99) 1000 tablet2025-05-01NoNoHistorical