bivalirudin

Generic: bivalirudin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bivalirudin
Generic Name bivalirudin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bivalirudin 250 mg/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-562
Product ID 63323-562_c6dcd639-86b8-40e0-b18b-e2d4393f274b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090189
Listing Expiration 2026-12-31
Marketing Start 2017-10-30

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 63323562
Hyphenated Format 63323-562

Supplemental Identifiers

RxCUI
308769
UPC
0363323562410
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 ANDA090189 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)
source: ndc

Packages (1)

63323-562-15 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)

Ingredients (1)

bivalirudin (250 mg/1)

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": "c6dcd639-86b8-40e0-b18b-e2d4393f274b", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0363323562410"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["50975be1-6d1f-497c-b989-1825a0fae1a7"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)", "package_ndc": "63323-562-15", "marketing_start_date": "20171030"}], "brand_name": "Bivalirudin", "product_id": "63323-562_c6dcd639-86b8-40e0-b18b-e2d4393f274b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "63323-562", "generic_name": "Bivalirudin", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "ANDA090189", "marketing_category": "ANDA", "marketing_start_date": "20171030", "listing_expiration_date": "20261231"}