Tirofiban
- Product NDC
- 55150-430
- 11-digit product format
- 551500430
- Labeler code
- 55150
- Product ID
- 55150-430_1751523a-e22e-4faf-bdb1-c850afe2fd36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tirofiban
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA216379
- Marketing category
- ANDA
- Marketing start
- 2023-05-01
- Substance
- TIROFIBAN HYDROCHLORIDE
- Active strength
- 12.5 mg/250mL
- Pharmacologic classes
- Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tirofiban
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIROFIBAN HYDROCHLORIDE | 12.5 mg/250mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6H925F8O5J |
| Rxcui | 1737466, 1737471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-430-01 | Tirofiban | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 55150-430-01 | Tirofiban | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-430 | TIROFIBAN INJECTION, SOLUTION [EUGIA US LLC] | 2 | Current NDC, 2 package rows | 20230714_d554acff-22e9-4f28-b826-ee1b91daa2df.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-430-01 | 55150043001 | 1 POUCH in 1 CARTON (55150-430-01) / 1 BAG in 1 POUCH / 250 mL in 1 BAG | 1 pouch | 2023-05-01 | No | No | Historical |