NDC 25208-001

AGGRASTAT

Tirofiban

AGGRASTAT is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Medicure International Inc. The primary component is Tirofiban Hydrochloride.

• Product ID: 25208-001_13dda5a4-808b-427a-8cff-0d83e11e2bec
• NDC: 25208-001
• Product Type: Human Prescription Drug
• Proprietary Name: AGGRASTAT
• Generic Name: Tirofiban
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-10-15
• Marketing Category: NDA / NDA
• Application Number: NDA020912
• Labeler Name: Medicure International Inc
• Substance Name: TIROFIBAN HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/15mL
• Pharm Classes: Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 25208-001-04

1 VIAL, GLASS in 1 CARTON (25208-001-04) > 15 mL in 1 VIAL, GLASS

• Marketing Start Date: 2016-10-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25208-001-04 [25208000104]

AGGRASTAT INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020912
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-10-15

Drug Details

Active Ingredients

Ingredient	Strength
TIROFIBAN HYDROCHLORIDE	3.75 mg/15mL

OpenFDA Data

• SPL SET ID: fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f
• Manufacturer:
  • Medicure International Inc
• UNII:
  • 6H925F8O5J
• RxNorm Concept Unique ID - RxCUI:
  • 1737468
  • 1737466
  • 1737471
  • 1737472
  • 1813037
  • 1813035

Pharmacological Class

• Decreased Platelet Aggregation [PE]
• Platelet Aggregation Inhibitor [EPC]

NDC Crossover Matching brand name "AGGRASTAT" or generic name "Tirofiban"

NDC	Brand Name	Generic Name
25208-001	AGGRASTAT	TIROFIBAN
25208-002	AGGRASTAT	TIROFIBAN
68083-145	Tirofiban hydrochloride	Tirofiban