Home NDC 69097-991 Ticagrelor
Product NDC 69097-991
11-digit product format 690970991
Labeler code 69097
Product ID 69097-991_d431b0b1-c7f9-40e4-9a30-6e778dcdde8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA208537
Marketing category ANDA
Marketing start 2025-05-01
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208537-001 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 A208537-002 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208537-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208537-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208537-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208537-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208537-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208537-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208537-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208537-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208537-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ticagrelor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TICAGRELOR 90 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GLH0314RVC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116635 Internal RxNorm lookup 1666332 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-991-03 Ticagrelor 60 in 1 PACKAGE TABLET, FILM COATED 60 2 69097-991-07 Ticagrelor 100 in 1 PACKAGE TABLET, FILM COATED 100 2 69097-991-12 Ticagrelor 500 in 1 PACKAGE TABLET, FILM COATED 500 2
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TICAGRELOR TICAGRELOR Aphena Pharma Solutions - Tennessee, LLC 37b2d081-c17a-c126-e063-6394a90a5729 2026-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208537 application number: ANDA208537 TICAGRELOR TICAGRELOR Exelan Pharmaceuticals, Inc eb8fb960-1f0e-40b1-9889-b02296bb3c37 2025-03-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208537 application number: ANDA208537 Ticagrelor TICAGRELOR Cipla USA Inc. 789606e3-9efa-440c-84f1-f1c56fcbf0cd 2025-03-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208537 application number: ANDA208537 ndc (product): 69097-991
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69097-991-03 69097099103 60 TABLET, FILM COATED in 1 PACKAGE (69097-991-03) 2025-05-01 No No Current 69097-991-07 69097099107 100 TABLET, FILM COATED in 1 PACKAGE (69097-991-07) 2025-05-01 No No Current 69097-991-12 69097099112 500 TABLET, FILM COATED in 1 PACKAGE (69097-991-12) 2025-05-01 No No Current