bivalirudin

Generic: bivalirudin

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bivalirudin
Generic Name bivalirudin
Labeler endo usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bivalirudin 250 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-622
Product ID 42023-622_e7641caf-d2f1-4a0e-a559-cd14aed68548
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211215
Listing Expiration 2026-12-31
Marketing Start 2023-06-19

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 42023622
Hyphenated Format 42023-622

Supplemental Identifiers

RxCUI
1997015
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 NDA211215 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

42023-622-01 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE 42023-622-10 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE

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": "e7641caf-d2f1-4a0e-a559-cd14aed68548", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["1997015"], "spl_set_id": ["91cf9d00-29e0-4357-a184-f70026c47edb"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01)  / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "42023-622-01", "marketing_start_date": "20230619"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10)  / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "42023-622-10", "marketing_start_date": "20230619"}], "brand_name": "Bivalirudin", "product_id": "42023-622_e7641caf-d2f1-4a0e-a559-cd14aed68548", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "42023-622", "generic_name": "Bivalirudin", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "NDA211215", "marketing_category": "NDA", "marketing_start_date": "20230619", "listing_expiration_date": "20261231"}