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 12 of 47 · 930 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sleepAESCULUS HIPPOCASTANUM, FLOS, FERRUM PHOS, KALI CARB, KALI PHOS, MAG PHOS, NAT MUR, POPULUS TERMULA, FLOS, PRUNUS CERASIFERA, FLOSSiddha Flower Essences LLCdc353895-3a58-475c-8afd-ab08b27b96c32025-12-31WarningsExact identifier
unii: 451W47IQ8X
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 451W47IQ8X
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: 451W47IQ8X
grief and lossCALC PHOS, CALC SULPH, CASTANEA SATIVA FLOS, IGNATIA AMARA, JUGLANS REGIA FLOS, KALI PHOS, NAT MUR, NAT SULPH, ORNITHOLAGUM UMBELLATUM FLOS, PHOS ACIDSiddha Flower Essences LLC1bb78196-303e-4c19-8bd9-d2add41ec52b2025-12-31WarningsExact identifier
unii: 451W47IQ8X
sightAESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEASiddha Flower Essences LLCe6a5a50f-873e-4aa0-ad66-ccfa70c75cde2025-12-31WarningsExact identifier
unii: 451W47IQ8X
mind and memoryAESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEASiddha Flower Essences LLC0d35b9a2-2123-4c14-b0b8-f45f3820ee032025-12-31WarningsExact identifier
unii: 451W47IQ8X
energy and motivationCALC SULPH, GENTIANA AMARELLA FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPEA FLOS, PHOS ACID, ULEX EUROPAEUS FLOSSiddha Flower Essences LLCaa69dd35-9866-40d7-9820-b01fc15be58a2025-12-31WarningsExact identifier
unii: 451W47IQ8X
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: 451W47IQ8X
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: 451W47IQ8X
Triple Allergy DefenseALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLANenningers Naturals, LLCe1459ef4-6980-4b2b-94c1-6c896a9cb6bd2025-12-25WarningsExact identifier
unii: 451W47IQ8X
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEJvet Pharmaceuticals LLCa84ddd02-1f5f-4311-9dae-2a5cb4064bf32025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 451W47IQ8X
Hair and Nail TonicAVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR.Eight and Company L.L.C35bda785-b3a7-4928-aaea-27bf9fb6abb52025-12-18WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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