TICAGRELOR
- Product NDC
- 76282-584
- 11-digit product format
- 762820584
- Labeler code
- 76282
- Product ID
- 76282-584_62c87369-6ec3-4cd5-82c6-a81c752be6ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TICAGRELOR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc
- Application
- ANDA208537
- Marketing category
- ANDA
- Marketing start
- 2025-10-29
- 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 |
|---|
| 76282-584-01 | TICAGRELOR | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 76282-584-05 | TICAGRELOR | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 76282-584-60 | TICAGRELOR | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76282-584-01 | 76282058401 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-584-01) | 2025-10-29 | No | No | Current |
| 76282-584-05 | 76282058405 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-584-05) | 2025-10-29 | No | No | Current |
| 76282-584-60 | 76282058460 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-584-60) | 2025-10-29 | No | No | Current |