bivalirudin

Generic: bivalirudin

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bivalirudin 250 mg/5mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-275
Product ID 16729-275_1fbdba30-8018-d7d3-e063-6294a90ae6b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206551
Listing Expiration 2026-12-31
Marketing Start 2018-11-07

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 16729275
Hyphenated Format 16729-275

Supplemental Identifiers

RxCUI
308769
UPC
0316729275033
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 ANDA206551 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)
source: ndc

Packages (1)

16729-275-67 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)

Ingredients (1)

bivalirudin (250 mg/5mL)

Linked Drug Pages (1)

Bivalirudin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1fbdba30-8018-d7d3-e063-6294a90ae6b6", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0316729275033"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["c20969cb-72d4-469b-9bd8-332250d896c3"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67)  / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)", "package_ndc": "16729-275-67", "marketing_start_date": "20181107"}], "brand_name": "Bivalirudin", "product_id": "16729-275_1fbdba30-8018-d7d3-e063-6294a90ae6b6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "16729-275", "generic_name": "bivalirudin", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/5mL"}], "application_number": "ANDA206551", "marketing_category": "ANDA", "marketing_start_date": "20181107", "listing_expiration_date": "20261231"}