FDA.reportPublic FDA data

NDC 60687-576-04 - 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
60687-576
Requested NDC
60687-576-04
Package NDCs from labels
60687-576-03, 60687-576-04, 60687-576-10, 60687-576-40, 60687-576-46, 60687-576-86
Manufacturer
American Health Packaging
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midazolam Hydrochloride - American Health PackagingAmerican Health Packaging2025-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-576-03Midazolam Hydrochloride2.5 mL in 1 CUP, UNIT-DOSESYRUP2.54
60687-576-04Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-10Midazolam Hydrochloride3 in 1 CASESYRUP34
60687-576-40Midazolam Hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP54
60687-576-46Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-86Midazolam Hydrochloride3 in 1 CASESYRUP34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-576MIDAZOLAM HYDROCHLORIDE SYRUP [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 6 package rows20250514_fc93242b-0abf-466a-8413-8a365620ee75.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-576-03ML - Milliliter60687-57619b9aac4-b9ad-4025-8426-02a466fcae8712021-06-02
60687-576-04ML - Milliliter60687-5765e70e6f4-498f-4f52-8520-c59b6e0d420e12021-07-15
60687-576-10ML - Milliliter60687-5769c4a46b0-1b7d-493d-9418-d1ca29f7c47112021-06-02
60687-576-40ML - Milliliter60687-576dd2b08e4-5041-431b-9949-5e91514b380912021-06-02
60687-576-46ML - Milliliter60687-576a6558fa5-5b77-4c0f-8528-d00b1a1cb1aa12021-07-15
60687-576-86ML - Milliliter60687-576c28e926a-e207-4057-9264-80f54b96b4b212021-06-02

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 34 · 665 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (package): 60687-576-04
ndc (package): 60687-576-86
ndc (package): 60687-576-40
ndc (package): 60687-576-10
ndc (package): 60687-576-03
ndc (package): 60687-576-46
ndc (product): 60687-576
ndc11 (package): 60687057604
rxcui: 422410
spl id: 57afebca-8a3d-c511-e063-6394a90a2cb0
spl set id: fc93242b-0abf-466a-8413-8a365620ee75
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
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
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 506T60A25R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MidazolamMIDAZOLAM HYDROCHLORIDEOnesource Specialty Pharma Limited54ed43b2-bad1-4b45-e063-6294a90a793a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R