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Active ingredient

Bivalirudin

15 finished FDA listings contain Bivalirudin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BIVALIRUDIN
Dosage forms
Injection, Injection, Powder, Lyophilized, For Solution, Injection, Powder, Lyophilized, For Suspension, Injection, Solution
Routes
Intracavernous, Intravenous
Manufacturers / labelers
13
Strengths listed
250 mg/1 · 250 mg/5ml

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 60819

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020873SANDOZ2000-12-152
ANDA 090189FRESENIUS KABI USA2016-10-282
ANDA 201577DR REDDYS2017-05-261
ANDA 206551ACCORD HLTHCARE2017-11-221
ANDA 202471MYLAN INSTITUTIONAL2018-06-011
ANDA 091602MEITHEAL2018-07-162
ANDA 205962EUGIA PHARMA2018-07-271
NDA 211215MAIA PHARMS INC2019-07-252
ANDA 210031SHUANGCHENG2019-10-232
ANDA 213078HAINAN POLY2021-05-281

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.