bivalirudin

Generic: bivalirudin

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bivalirudin
Generic Name bivalirudin
Labeler slate run pharmaceuticals, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

bivalirudin 250 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-025
Product ID 70436-025_c44f8757-1a09-ab1e-e053-2a95a90a44e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213078
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

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 70436025
Hyphenated Format 70436-025

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 ANDA213078 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80)
  • 10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82)
source: ndc

Packages (2)

70436-025-80 1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80) 70436-025-82 10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82)

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": "c44f8757-1a09-ab1e-e053-2a95a90a44e1", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["5d9a45c6-e234-4d56-9132-5e24e65852e6"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80)", "package_ndc": "70436-025-80", "marketing_start_date": "20210630"}, {"sample": false, "description": "10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82)", "package_ndc": "70436-025-82", "marketing_start_date": "20210630"}], "brand_name": "bivalirudin", "product_id": "70436-025_c44f8757-1a09-ab1e-e053-2a95a90a44e1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "70436-025", "generic_name": "bivalirudin", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "ANDA213078", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}