tirofiban hydrochloride

Generic: tirofiban

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tirofiban hydrochloride
Generic Name tirofiban
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tirofiban hydrochloride 12.5 mg/250mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-145
Product ID 68083-145_a206685a-4e0d-40a1-8f39-a4b2f660d7d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206888
Listing Expiration 2026-12-31
Marketing Start 2021-04-15

Pharmacologic Class

Classes
decreased platelet aggregation [pe] platelet aggregation inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083145
Hyphenated Format 68083-145

Supplemental Identifiers

RxCUI
1737471
UPC
0368083145019
UNII
6H925F8O5J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tirofiban hydrochloride (source: ndc)
Generic Name tirofiban (source: ndc)
Application Number ANDA206888 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/250mL
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINER
source: ndc

Packages (1)

68083-145-01 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINER

Ingredients (1)

tirofiban hydrochloride (12.5 mg/250mL)

Linked Drug Pages (1)

Tirofiban hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a206685a-4e0d-40a1-8f39-a4b2f660d7d7", "openfda": {"upc": ["0368083145019"], "unii": ["6H925F8O5J"], "rxcui": ["1737471"], "spl_set_id": ["fa3ac570-f9f6-474c-a920-bd0cf03045ac"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (68083-145-01)  / 250 mL in 1 CONTAINER", "package_ndc": "68083-145-01", "marketing_start_date": "20210415"}], "brand_name": "Tirofiban hydrochloride", "product_id": "68083-145_a206685a-4e0d-40a1-8f39-a4b2f660d7d7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "68083-145", "generic_name": "Tirofiban", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tirofiban hydrochloride", "active_ingredients": [{"name": "TIROFIBAN HYDROCHLORIDE", "strength": "12.5 mg/250mL"}], "application_number": "ANDA206888", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}