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 41 of 47 · 930 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yonis BlissCHAMOMILLA, NATRUM MURIATICUMBrookhaus Essentials LLCea4091d6-d295-41a0-aae5-68f3c260e1102022-11-30WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: 451W47IQ8X
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: 451W47IQ8X
Midazolam hydrochlorideMIDAZOLAM HYDROCHLORIDEGland Pharma Limited23f4df96-1151-4815-8f01-4d79e5aa21452022-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1666798
unii: W7TTW573JJ
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation123bd10a-90c7-499e-97f6-acf7e0f0fb4e2022-07-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCfad9615f-7004-415d-9f69-ee9ff95f00672022-07-12WarningsExact identifier
unii: 451W47IQ8X
BHI ConstipationDIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEEDMediNatura Inc0365b75b-fee4-4c1d-89ab-c692bdd73f752022-07-07WarningsExact identifier
unii: 451W47IQ8X
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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