FDA.reportPublic FDA data

NDC 0409-2305-55 - 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
0409-2305
Requested NDC
0409-2305-55
Package NDCs from labels
0409-2305-16, 0409-2305-17, 0409-2305-04, 0409-2305-05, 0409-2305-55, 0409-2305-50
Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midazolam - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-08-12HUMAN PRESCRIPTION DRUG LABEL
MIDAZOLAM - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-08-12HUMAN PRESCRIPTION DRUG LABEL
Midazolam - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-10HUMAN PRESCRIPTION DRUG LABEL
MIDAZOLAM - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2020-03-11HUMAN PRESCRIPTION DRUG LABEL
MIDAZOLAM HYDROCHLORIDE - Cardinal HealthCardinal Health2019-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2305-04Midazolam5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION534
0409-2305-05Midazolam10 in 1 CARTONINJECTION, SOLUTION1034
0409-2305-16Midazolam2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION234
0409-2305-17Midazolam25 in 1 TRAYINJECTION, SOLUTION2534
0409-2305-50MIDAZOLAM10 in 1 CARTONINJECTION, SOLUTION1018
0409-2305-55MIDAZOLAM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2305MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]31Current NDC, Legacy NDC, 4 package rows20250129_1abda8b8-48a8-4995-af86-39220d1aa240.zip
0409-2305MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]16Current NDC, Legacy NDC, 2 package rows20241201_b95415fa-17c2-42ab-a6b0-e628d01c94ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2305-02ML - Milliliter0409-230598253dc2-cea7-4525-a3ba-8501b7f6c5e812012-07-24
0409-2305-04ML - Milliliter0409-2305de4bce48-0fc0-4223-a261-039c00a587b612020-02-13
0409-2305-05ML - Milliliter0409-230512e3eb93-2779-475c-8b8e-bc237591d2ba12012-07-24
0409-2305-16ML - Milliliter0409-23055e7e3c5f-a976-4520-a459-62f2ff11d86412020-02-13
0409-2305-17ML - Milliliter0409-2305f88f3d1d-297c-4e57-870c-977b5c1ce9d512012-07-24
0409-2305-21ML - Milliliter0409-2305c87b68e3-5cb3-470e-bb01-4524645ba74b12012-07-24
0409-2305-49ML - Milliliter0409-2305fab609b7-2497-4d17-b98f-d436db9dab6c12012-07-24
0409-2305-50ML - Milliliter0409-2305a54d35d2-1118-4ee2-93bf-46a2179969e012012-07-24
0409-2305-55ML - Milliliter0409-2305419c9af9-b6c3-42b3-bbe5-5d5ae95028ca12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]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 47 · 930 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 451W47IQ8X
Natural Lift Lack of energy - FatigueAVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9CSEVENE USA551194c4-dfd8-c42d-e063-6294a90aecee2026-08-13WarningsExact identifier
unii: 451W47IQ8X
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 451W47IQ8X
MIDAZOLAMMIDAZOLAM HYDROCHLORIDEHospira, Inc.b95415fa-17c2-42ab-a6b0-e628d01c94ed2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075857
ndc (package): 0409-2305-50
ndc (package): 0409-2308-69
ndc (package): 0409-2308-49
ndc (package): 0409-2308-70
ndc (package): 0409-2308-50
ndc (package): 0409-2305-55
ndc (product): 0409-2308
ndc (product): 0409-2305
ndc11 (package): 00409230555
rxcui: 1666800
rxcui: 1666814
rxcui: 1666823
spl id: 2f69c5b1-6505-42dc-8bb3-edbd9b6c0781
spl set id: b95415fa-17c2-42ab-a6b0-e628d01c94ed
unii: W7TTW573JJ
MidazolamMIDAZOLAM HYDROCHLORIDEOnesource Specialty Pharma Limiteda0e9a149-7a4c-4f66-91af-91695ee2e40c2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
MidazolamMIDAZOLAM HYDROCHLORIDEHospira, Inc.1abda8b8-48a8-4995-af86-39220d1aa2402026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075857
ndc (package): 0409-2308-21
ndc (package): 0409-2305-04
ndc (package): 0409-2308-02
ndc (package): 0409-2305-05
ndc (package): 0409-2305-17
ndc (package): 0409-2308-01
ndc (package): 0409-0001-01
ndc (package): 0409-2308-22
ndc (package): 0409-2305-16
ndc (package): 0409-0001-25
ndc (product): 0409-2308
ndc (product): 0409-2305
ndc (product): 0409-0001
rxcui: 1666800
rxcui: 1666814
rxcui: 1666823
rxcui: 1666798
spl id: 8954486a-8512-4831-8178-0b49f1efb73e
spl set id: 1abda8b8-48a8-4995-af86-39220d1aa240
unii: W7TTW573JJ
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: 451W47IQ8X
AdrenapathCARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE)Energetix Corporationc300b8f5-4334-4597-a303-8200cbc117d12026-08-11WarningsExact identifier
unii: 451W47IQ8X
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: 451W47IQ8X
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: 451W47IQ8X
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 451W47IQ8X
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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