bivalirudin

Generic: bivalirudin

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bivalirudin
Generic Name bivalirudin
Labeler dr. reddy's laboratories limited
Dosage Form INJECTION
Routes
INTRACAVERNOUS
Active Ingredients

bivalirudin 250 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-652
Product ID 55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201577
Listing Expiration 2026-12-31
Marketing Start 2017-05-31

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 55111652
Hyphenated Format 55111-652

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 ANDA201577 (source: ndc)
Routes
INTRACAVERNOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)
source: ndc

Packages (1)

55111-652-37 10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)

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": ["INTRACAVERNOUS"], "spl_id": "2c95d0ae-12a5-4981-d4cf-99e26a7f5a69", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["TN9BEX005G"], "rxcui": ["308769"], "spl_set_id": ["19beb2ae-6064-3c24-fe50-0cee86896979"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37)  / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)", "package_ndc": "55111-652-37", "marketing_start_date": "20170531"}], "brand_name": "Bivalirudin", "product_id": "55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "55111-652", "generic_name": "Bivalirudin", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bivalirudin", "active_ingredients": [{"name": "BIVALIRUDIN", "strength": "250 mg/1"}], "application_number": "ANDA201577", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20261231"}