bivalirudin

Generic: bivalirudin

Labeler: civica, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

bivalirudin 250 mg/1

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-035
Product ID 72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020873
Listing Expiration 2026-12-31
Marketing Start 2020-12-21

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 72572035
Hyphenated Format 72572-035

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 NDA020873 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)
source: ndc

Packages (1)

72572-035-10 10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)

Ingredients (1)

bivalirudin (250 mg/1)

Linked Drug Pages (1)

bivalirudin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "53431803-dc0b-42dc-8766-e17c3dbdf4ea", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["19a4afc5-151d-4d3c-bfef-48aa8797d695"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)", "package_ndc": "72572-035-10", "marketing_start_date": "20201221"}], "brand_name": "bivalirudin", "product_id": "72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "72572-035", "generic_name": "bivalirudin", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "NDA020873", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20201221", "listing_expiration_date": "20261231"}