Tirofiban hydrochloride
- Product NDC
- 68083-145
- 11-digit product format
- 680830145
- Labeler code
- 68083
- Product ID
- 68083-145_a206685a-4e0d-40a1-8f39-a4b2f660d7d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tirofiban
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA206888
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- 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 hydrochloride
- 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 | 1737471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-145-01 | Tirofiban hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 68083-145-01 | Tirofiban hydrochloride | 250 mL in 1 CONTAINER | INJECTION, SOLUTION | 250 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-145 | TIROFIBAN HYDROCHLORIDE (TIROFIBAN) INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20210520_fa3ac570-f9f6-474c-a920-bd0cf03045ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-145-01 | 68083014501 | 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINER | 1 container | 2021-04-15 | 0000-00-00 | No | No | Current |