Ticagrelor
- Product NDC
- 42658-115
- 11-digit product format
- 426580115
- Labeler code
- 42658
- Product ID
- 42658-115_4bdf0e1b-391f-302e-e063-6294a90ac357
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ticagrelor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hisun Pharmaceuticals USA, Inc.
- Application
- ANDA208575
- 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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GLH0314RVC |
| Rxcui | 1116635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42658-115-03 | Ticagrelor | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
| 42658-115-07 | Ticagrelor | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
| 42658-115-10 | Ticagrelor | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42658-115 | TICAGRELOR TABLET, FILM COATED [HISUN PHARMACEUTICALS USA, INC.] | 9 | Current NDC, 3 package rows | 20250105_c4c1ca82-99bd-451a-ad77-7fe28c4ae3e8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42658-115-03 | 42658011503 | 60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) | 2025-05-01 | No | No | Historical |
| 42658-115-07 | 42658011507 | 500 in 1 BOTTLE | | | | Historical |
| 42658-115-10 | 42658011510 | 180 in 1 BOTTLE | | | | Historical |