FDA Orange Book · active-ingredient family
Midazolam hydrochloride
Midazolam hydrochloride: 4 brands, 36 generics; first approved Dec 20, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 36 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
36
Listed patents
0
Presentations
63
Brand (NDA) products
Originator applications
- RAFA LABS LTDNDA 2163592022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) SOLUTION INTRAMUSCULAR Rx — - SEIZALAMRLDMMTNDA 2095662018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/10ML (EQ 5MG BASE/ML) SOLUTION INTRAMUSCULAR Discontinued — - VERSEDRLDROCHENDA 0209421998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Discontinued — - VERSEDRLDHLRNDA 01865419872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (36)
Abbreviated applications
- MIDAZOLAM HYDROCHLORIDEMICRO LABSANDA 21750420232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHIKMAANDA 21284720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEFRESENIUS KABI USAANDA 2088782017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 20346020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTDANDA 0906962012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTDANDA 0908502012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - ONESOURCE SPECIALTYANDA 09031620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - ONESOURCE SPECIALTYANDA 09031520102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEPH HEALTHANDA 07851120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEPH HEALTHANDA 07814120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEPHARM ASSOCANDA 0771152005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Discontinued — - MIDAZOLAM HYDROCHLORIDEPADAGIS USANDA 0763792005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Rx AA - MIDAZOLAM HYDROCHLORIDEINTL MEDICATEDANDA 07614420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEINTL MEDICATIONANDA 07602020042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEPAI HOLDINGSANDA 0759582003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Discontinued — - HOSPIRAANDA 07585720022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHOSPIRAANDA 07585620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDERSHIKMAANDA 0758732002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Rx AA - MIDAZOLAM HYDROCHLORIDESUN PHARM INDS LTDANDA 0760582002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML SYRUP ORAL Discontinued — - MIDAZOLAM HYDROCHLORIDEAPOTHECONANDA 07562020002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 07563720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEAPOTHECONANDA 0756412000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEEPIC PHARMA LLCANDA 0754812000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDERISINGANDA 07549420002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEIGI LABS INCANDA 0752632000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEBEDFORDANDA 0752492000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEHIKMAANDA 07524720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEBEN VENUEANDA 0754552000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEFRESENIUS KABI USAANDA 07515420002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHIKMAANDA 07524320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHIKMAANDA 07532420002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHIKMAANDA 07542120002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDERSHOSPIRAANDA 07529320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MIDAZOLAM HYDROCHLORIDEHOSPIRAANDA 07539620002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEHOSPIRAANDA 0754842000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MIDAZOLAM HYDROCHLORIDEHOSPIRA INCANDA 07540920002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
41 yr 5 mo ago
Most recent approval
3 yr 2 mo ago
Approvals span 1985–2023 across 40 FDA applications.
Brand (NDA) 410%
Generic (ANDA) 3690%
Midazolam hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
