FDA.reportPublic FDA data

NDC 55648-762-07 - Midazolam hydrochloride

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
55648-762
Requested NDC
55648-762-07
Package NDCs from labels
55648-762-07, 55648-762-01, 55648-762-04, 55648-762-08, 55648-762-02, 55648-762-05, 55648-762-09, 55648-762-03, 55648-762-06
Manufacturer
Wockhardt Limited
Effective date
2012-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Midazolam hydrochloride - Wockhardt LimitedWockhardt Limited2012-11-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
55648-762-01MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-762-02MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-762-03MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-762-04MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-762-05MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
55648-762-06MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-762-01Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-762-02Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-762-03Midazolam hydrochloride10 in 1 CARTONINJECTION101
55648-762-04Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-762-05Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-762-06Midazolam hydrochloride25 in 1 CARTONINJECTION251
55648-762-07Midazolam hydrochloride2 mL in 1 VIALINJECTION21
55648-762-08Midazolam hydrochloride5 mL in 1 VIALINJECTION51
55648-762-09Midazolam hydrochloride10 mL in 1 VIALINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-762MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1Legacy NDC, 9 package rows20121119_19fbdc82-a727-4345-b67e-d0fd620defca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIDAZOLAM HYDROCHLORIDEACTIVE INGREDIENTW7TTW573JJMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
MIDAZOLAMACTIVE MOIETYR60L0SM5BCMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]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 3 of 46 · 909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEA-S Medication Solutions5e85e477-d483-4345-8d7b-d7dcdc3e06522026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311702
unii: W7TTW573JJ
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEAmerican Health Packagingfc93242b-0abf-466a-8413-8a365620ee752026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
MidazolamMIDAZOLAM HYDROCHLORIDEOnesource Specialty Pharma Limited54ed43b2-bad1-4b45-e063-6294a90a793a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ
MidazolamMIDAZOLAMCivica, Inc.f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: W7TTW573JJ

Reported adverse events (FAERS/openFDA)#

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