Ticagrelor
- Product NDC
- 72603-941
- Requested package NDC
- 72603-941-01
- 11-digit product format
- 726030941
- Labeler code
- 72603
- Product ID
- 72603-941_c89c29c9-d2c0-4605-b74f-059e0b104977
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ticagrelor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA212258
- Marketing category
- ANDA
- Marketing start
- 2026-08-10
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212258-001 | TICAGRELOR | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | |
| A212258-002 | TICAGRELOR | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212258-001 | AB |
| A212258-002 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212258-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212258-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212258-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212258-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-002 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-002 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ticagrelor
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TICAGRELOR | 90 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| GLH0314RVC | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c89c29c9-d2c0-4605-b74f-059e0b104977 | Available on FDA.report |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ticagrelor | TICAGRELOR | Macleods Pharmaceuticals Limited | 32769721-c1dd-4bd3-90aa-a6cab59d3cd6 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 212258 ANDA212258 |
| Ticagrelor | TICAGRELOR | NorthStar RxLLC | c89c29c9-d2c0-4605-b74f-059e0b104977 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 212258 ANDA212258 72603-941-01 72603-941 72603094101 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72603-941-01 | 72603094101 | 60 TABLET, FILM COATED in 1 BOTTLE (72603-941-01) | 2026-08-10 | No | No | Current |