FDA.reportPublic FDA data

NDC 63323-412-06 - Midazolam

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
63323-412
Requested NDC
63323-412-06
Package NDCs from labels
63323-412-00, 63323-412-18, 63323-412-25, 63323-412-03, 63323-412-02, 63323-412-06, 63323-412-05, 63323-412-13, 63323-412-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midazolam - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-11-26HUMAN PRESCRIPTION DRUG LABEL
Midazolam - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-412-02Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-03Midazolam2 mL in 1 VIALINJECTION, SOLUTION27
63323-412-05Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-06Midazolam5 mL in 1 VIALINJECTION, SOLUTION57
63323-412-10Midazolam10 in 1 TRAYINJECTION, SOLUTION107
63323-412-13Midazolam10 mL in 1 VIALINJECTION, SOLUTION107
63323-412-18Midazolam1 mL in 1 VIALINJECTION, SOLUTION17
63323-412-25Midazolam25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-412MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 8 package rows20240806_a91ce254-14a3-4cbf-8ab8-5da252aa3fdc.zip
63323-412MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC20241031_09daf48f-1d44-4b7b-bb53-bd5635b93ca6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-412-02ML - Milliliter63323-4128efc1412-9341-407f-8f72-b8f5b766deea12013-02-13
63323-412-03ML - Milliliter63323-4124b1d71cf-cbc3-4acf-b5f8-e874d80e51f012019-10-07
63323-412-05ML - Milliliter63323-412882430ae-195a-4c1f-bcc3-4d84f685c3b912013-02-13
63323-412-06ML - Milliliter63323-4121e201941-c71f-44ac-9e1f-fc7d1310890512019-10-07
63323-412-10ML - Milliliter63323-412f3d9824f-c81d-4c0a-a1d5-19edfce62fc712013-02-13
63323-412-13ML - Milliliter63323-412ec1f0dac-d3c3-48d1-a934-beb19d3c683012019-10-07
63323-412-18ML - Milliliter63323-41253679acb-42ac-40d1-a457-69fdf9d7a05c12019-10-07
63323-412-25ML - Milliliter63323-412d0d9cb42-66d0-4cd5-88dc-0bdf5e1dc61b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]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 5 of 48 · 960 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEPrecision Dose Inc.9a443652-6aff-4e27-83fe-90c65fa0f3c12026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
628ec2ba-8514-4bfc-a779-b7df98e77b8e09daf48f-1d44-4b7b-bb53-bd5635b93ca62026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 09daf48f-1d44-4b7b-bb53-bd5635b93ca6
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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