FDA.reportPublic FDA data

Ticagrelor

Product NDC
67877-522
Requested package NDC
67877-522-38
11-digit product format
678770522
Labeler code
67877
Product ID
67877-522_0e2da4e0-7930-4f20-a63e-bd8b75cfb47d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ticagrelor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210219
Marketing category
ANDA
Marketing start
2025-10-28
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210219-001TICAGRELORTICAGRELOR60MGTABLET / ORALAB2025-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210219-001AB

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
2026-02-19 14:30 UTC2026-02A210219-001TICAGRELOR60MGTABLET / ORALAB2025-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210219-001TICAGRELOR60MGTABLET / ORALAB2025-10-2831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210219-001TICAGRELOR60MGTABLET / ORALAB2025-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210219-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210219-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210219-001AB1a50c72e98297…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
3225098b-3138-4aec-a866-de94c3006e8eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2b3fae0e-1168-2920-6fac-e67420589ce0Product name920260113
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-522-05Ticagrelor500 in 1 BOTTLETABLET, FILM COATED50010
67877-522-14Ticagrelor14 in 1 BOTTLETABLET, FILM COATED1410
67877-522-18Ticagrelor180 in 1 BOTTLETABLET, FILM COATED18010
67877-522-38Ticagrelor10 in 1 BLISTER PACKTABLET, FILM COATED1010
67877-522-38Ticagrelor10 in 1 CARTONTABLET, FILM COATED1010
67877-522-60Ticagrelor60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-522-60EA - Each67877-522d0ecff83-17e0-4a21-bcf9-df9d99b6972f12025-11-13

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
TicagrelorTICAGRELORAscend Laboratories, LLC3225098b-3138-4aec-a866-de94c3006e8e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210219
application number: ANDA210219
ndc (package): 67877-522-38
ndc (product): 67877-522
ndc11 (package): 67877052238

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666332ticagrelor 60 MG Oral TabletPSN3225098b-3138-4aec-a866-de94c3006e8e10
1666332ticagrelor 60 MG Oral TabletSCD3225098b-3138-4aec-a866-de94c3006e8e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-522-386787705223810 BLISTER PACK in 1 CARTON (67877-522-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-10-28NoNoCurrent