Ticagrelor
- Product NDC
- 46708-500
- 11-digit product format
- 467080500
- Labeler code
- 46708
- Product ID
- 46708-500_ef3c94fb-69c7-4649-874d-bb4bedc1152d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ticagrelor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA208576
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ticagrelor
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TICAGRELOR | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GLH0314RVC |
| Rxcui | 1116635, 1666332 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-500-60 | Ticagrelor | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 46708-500-71 | Ticagrelor | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-500-60 | 46708050060 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-500-60) | 2025-10-28 | No | No | Current |
| 46708-500-71 | 46708050071 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-500-71) | 2025-10-28 | No | No | Current |