FDA.reportPublic FDA data

NDC 68094-764-59 - Midazolam Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68094-764
Requested NDC
68094-764-59
Package NDCs from labels
68094-764-59, 68094-764-62
Manufacturer
Precision Dose Inc.
Effective date
2026-05-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MIDAZOLAM HYDROCHLORIDE SYRUP CIVPrecision Dose Inc.2026-05-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-764-59Midazolam Hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP55
68094-764-62Midazolam Hydrochloride10 in 1 TRAYSYRUP105
68094-764-62Midazolam Hydrochloride3 in 1 CASESYRUP35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-764MIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 3 package rows20231230_9a443652-6aff-4e27-83fe-90c65fa0f3c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-764-59ML - Milliliter68094-7643a073d75-0e61-4221-a508-706cab210c0912015-06-09
68094-764-62ML - Milliliter68094-76446a3081f-d43c-4be9-809a-8063c48b676a12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Midazolam HydrochlorideACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
MidazolamACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 34 · 665 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEA-S Medication Solutions5e85e477-d483-4345-8d7b-d7dcdc3e06522026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEAmerican Health Packagingfc93242b-0abf-466a-8413-8a365620ee752026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075873
rxcui: 422410
unii: W7TTW573JJ
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.