FDA.reportPublic FDA data

Ticagrelor

Product NDC
43598-480
11-digit product format
435980480
Labeler code
43598
Product ID
43598-480_b3d72d98-872a-adfa-108f-3c2c60fe8703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA208541
Marketing category
ANDA
Marketing start
2025-04-30
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, 1666332

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-480-60EA - Each43598-4809360ffca-6e06-43db-984f-612528f4cf7a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-480TICAGRELOR TABLET [DR. REDDYS LABORATORIES INC]18Current NDC20250430_1225fd45-9b56-1671-ee77-cd0c9f2174a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN1225fd45-9b56-1671-ee77-cd0c9f2174a522
1116635ticagrelor 90 MG Oral TabletPSN1225fd45-9b56-1671-ee77-cd0c9f2174a522
1666332ticagrelor 60 MG Oral TabletSCD1225fd45-9b56-1671-ee77-cd0c9f2174a522
1116635ticagrelor 90 MG Oral TabletSCD1225fd45-9b56-1671-ee77-cd0c9f2174a522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-480-1843598048018180 TABLET in 1 BOTTLE (43598-480-18) 180 tablet2025-04-30NoNoCurrent
43598-480-604359804806060 TABLET in 1 BOTTLE (43598-480-60) 60 tablet2025-04-30NoNoCurrent
43598-480-784359804807810 BLISTER PACK in 1 CARTON (43598-480-78) / 10 TABLET in 1 BLISTER PACK10 blister pack2025-04-30NoNoCurrent
43598-480-79435980480791 BLISTER PACK in 1 CARTON (43598-480-79) / 10 TABLET in 1 BLISTER PACK1 blister pack2025-04-30NoNoCurrent