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 22 of 47 · 930 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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