Ticagrelor

Product NDC
70756-047
11-digit product format
707560047
Labeler code
70756
Product ID
70756-047_bb3d8f46-1914-4487-8c24-fd6699e8f993
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217679
Marketing category
ANDA
Marketing start
2026-02-06
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217679-001TICAGRELORTICAGRELOR60MGTABLET / ORALAB2026-02-06
A217679-002TICAGRELORTICAGRELOR90MGTABLET / ORALAB2026-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217679-001AB
A217679-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217679-001TICAGRELOR60MGTABLET / ORALAB2026-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217679-002TICAGRELOR90MGTABLET / ORALAB2026-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217679-001TICAGRELOR60MGTABLET / ORALAB2026-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217679-002TICAGRELOR90MGTABLET / ORALAB2026-02-06011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217679-001TICAGRELOR60MGTABLET / ORALAB2026-02-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217679-002TICAGRELOR90MGTABLET / ORALAB2026-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217679-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217679-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217679-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217679-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217679-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217679-002AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GLH0314RVCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116635Internal RxNorm lookup
1666332Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7efe86fa-5d19-413a-8b15-e51279b62f3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-047-60Ticagrelor60 in 1 BOTTLETABLET, FILM COATED6010

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TicagrelorTICAGRELORLifestar Pharma LLC7efe86fa-5d19-413a-8b15-e51279b62f3f2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217679
application number: ANDA217679
ndc (product): 70756-047

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN7efe86fa-5d19-413a-8b15-e51279b62f3f10
1116635ticagrelor 90 MG Oral TabletPSN7efe86fa-5d19-413a-8b15-e51279b62f3f10
1666332ticagrelor 60 MG Oral TabletSCD7efe86fa-5d19-413a-8b15-e51279b62f3f10
1116635ticagrelor 90 MG Oral TabletSCD7efe86fa-5d19-413a-8b15-e51279b62f3f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-047-607075600476060 TABLET, FILM COATED in 1 BOTTLE (70756-047-60) 2026-02-06NoNoCurrent