bivalirudin

Generic: bivalirudin

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bivalirudin
Generic Name bivalirudin
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bivalirudin 250 mg/5mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-427
Product ID 71288-427_79d8ee9d-bd04-4fb8-aa3b-61cef7be14f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091602
Listing Expiration 2026-12-31
Marketing Start 2018-07-16

Pharmacologic Class

Established (EPC)
anti-coagulant [epc] direct thrombin inhibitor [epc]
Mechanism of Action
thrombin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288427
Hyphenated Format 71288-427

Supplemental Identifiers

RxCUI
308769
UNII
TN9BEX005G
NUI
N0000175980 N0000175518 N0000009963

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 bivalirudin (source: ndc)
Generic Name bivalirudin (source: ndc)
Application Number ANDA091602 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91)
source: ndc

Packages (1)

71288-427-92 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91)

Ingredients (1)

bivalirudin (250 mg/5mL)

Linked Drug Pages (2)

BIVALIRUDIN ndc-match (0.9) BIVALIRUDIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "79d8ee9d-bd04-4fb8-aa3b-61cef7be14f2", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["26fb46f6-0088-42b8-b6f2-c67224776803"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-92)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-91)", "package_ndc": "71288-427-92", "marketing_start_date": "20180716"}], "brand_name": "BIVALIRUDIN", "product_id": "71288-427_79d8ee9d-bd04-4fb8-aa3b-61cef7be14f2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "71288-427", "generic_name": "BIVALIRUDIN", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BIVALIRUDIN", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/5mL"}], "application_number": "ANDA091602", "marketing_category": "ANDA", "marketing_start_date": "20180716", "listing_expiration_date": "20261231"}