Ticagrelor
- Product NDC
- 0378-2214
- 11-digit product format
- 003782214
- Labeler code
- 0378
- Product ID
- 0378-2214_fc333c4a-ad63-4d67-a3f7-431ac469d116
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ticagrelor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208597
- Marketing category
- ANDA
- Marketing start
- 2025-09-25
- 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 |
|---|
| 0378-2214-05 | Ticagrelor | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 1 |
| 0378-2214-80 | Ticagrelor | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 1 |
| 0378-2214-91 | Ticagrelor | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-2214-05 | 00378221405 | 500 in 1 BOTTLE, PLASTIC | | | | Historical |
| 0378-2214-80 | 00378221480 | 180 in 1 BOTTLE, PLASTIC | | | | Historical |
| 0378-2214-91 | 00378221491 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91) | 2025-09-25 | No | No | Historical |