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Active ingredient

Midazolam

79 finished FDA listings contain Midazolam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM MALEATE
Dosage forms
Injection, Injection, Solution, Spray, Syrup
Routes
Intramuscular, Intravenous, Nasal, Oral
Manufacturers / labelers
26
Strengths listed
1 mg/ml · 10 mg/.7ml · 10 mg/2ml · 2 mg/2ml · 2 mg/ml · 5 mg/.1ml · 5 mg/5ml · 5 mg/ml
Brand names in FDA listings
Midazolam, Midazolam In Sodium Chloride, Nayzilam

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6960

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
ANDA 075154FRESENIUS KABI USA2000-06-202
ANDA 075293HOSPIRA2000-06-205
ANDA 075243HIKMA2000-06-2016
ANDA 075873HIKMA2002-04-304
ANDA 075857HOSPIRA2002-07-227
ANDA 076379PADAGIS US2005-05-022
ANDA 090315ONESOURCE SPECIALTY2010-11-297
ANDA 090316ONESOURCE SPECIALTY2011-05-047
ANDA 090850GLAND PHARMA LTD2012-01-255
ANDA 090696GLAND PHARMA LTD2012-02-293
ANDA 203460FRESENIUS KABI USA2014-08-224
NDA 211321UCB INC2019-05-171
ANDA 212847HIKMA2020-12-113
NDA 211844INFORLIFE2021-03-222
NDA 216359RAFA LABS LTD2022-08-081
ANDA 216159HIKMA2023-04-172
ANDA 217504MICRO LABS2023-08-212
ANDA 218993GLAND2024-08-124
ANDA 218454B BRAUN MEDICAL2025-05-012

Official labeling on DailyMed

Showing the 12 most recent of 46 labels.

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