FDA.reportPublic FDA data

NDC 0409-9558-69 - ROCURONIUM BROMIDE

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
0409-9558
Requested NDC
0409-9558-69
Package NDCs from labels
0409-9558-69, 0409-9558-49, 0409-9558-70, 0409-9558-50, 0409-9558-11, 0409-9558-05, 0409-9558-31, 0409-9558-10
Manufacturer
Hospira, Inc. | Hospira Worldwide, LLC
Effective date
2026-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROCURONIUM BROMIDE - Hospira, Inc. | Hospira Worldwide, LLCHospira, Inc. | Hospira Worldwide, LLC2026-04-15HUMAN PRESCRIPTION DRUG LABEL
Rocuronium Bromide - Hospira, Inc. | Hospira Worldwide, LLCHospira, Inc. | Hospira Worldwide, LLC2026-03-09HUMAN PRESCRIPTION DRUG LABEL
ROCURONIUM BROMIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-28HUMAN PRESCRIPTION DRUG LABEL
Rocuronium Bromide - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-03HUMAN PRESCRIPTION DRUG LABEL
ROCURONIUM BROMIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2021-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-9558-05Rocuronium Bromide10 in 1 BOXINJECTION, SOLUTION1029
0409-9558-10Rocuronium Bromide10 in 1 BOXINJECTION, SOLUTION1029
0409-9558-11Rocuronium Bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION529
0409-9558-31Rocuronium Bromide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1029
0409-9558-49ROCURONIUM BROMIDE10 in 1 BOXINJECTION, SOLUTION1014
0409-9558-50ROCURONIUM BROMIDE10 in 1 BOXINJECTION, SOLUTION1014
0409-9558-69ROCURONIUM BROMIDE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION514
0409-9558-70ROCURONIUM BROMIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9558ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 4 package rows20241122_309aeb1b-8022-4df7-8194-ae6529e3395c.zip
0409-9558ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]12Current NDC, Legacy NDC, 4 package rows20241122_cccd40ca-5f08-4acb-8548-3cad558388bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9558-05ML - Milliliter0409-955876ef3541-29b6-4894-b97a-6de05914c0f512012-07-24
0409-9558-10ML - Milliliter0409-95583a085b04-cdb3-4642-8f63-1a0303b04fd212012-07-24
0409-9558-11ML - Milliliter0409-955867418593-3473-4d6a-8e00-203b5591f8e112020-01-03
0409-9558-31ML - Milliliter0409-9558f0a0badc-151a-4891-9f33-c7540517b78312020-02-13
0409-9558-49ML - Milliliter0409-955848aace5d-1ceb-48c5-9487-0aef323e324e12012-07-24
0409-9558-50ML - Milliliter0409-9558d83e760d-a00b-4365-8396-7c46bc261bb512012-07-24
0409-9558-69ML - Milliliter0409-9558b6d4c76a-bde5-41b3-a6ed-d81c4c006b2212020-02-13
0409-9558-70ML - Milliliter0409-955889be01fb-24c3-4f9c-8eb4-ecee46c06c3112020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2

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 5 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rocuronium BromideROCURONIUM BROMIDEEugia US LLC116385ea-69fc-4f44-b463-6210291032df2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 1234995
unii: I65MW4OFHZ
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: Q40Q9N063P
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ROCURONIUM BROMIDEROCURONIUM BROMIDEMedical Purchasing Solutions, LLC4f9bf2d0-5702-4610-e063-6294a90a2cd92026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 1234995
unii: I65MW4OFHZ
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ROCURONIUM BROMIDEROCURONIUM BROMIDEHospira, Inc.cccd40ca-5f08-4acb-8548-3cad558388bb2026-04-15Warnings, Adverse reactionsExact identifier
application number: ANDA078519
ndc (package): 0409-9558-49
ndc (package): 0409-9558-69
ndc (package): 0409-9558-70
ndc (package): 0409-9558-50
ndc (product): 0409-9558
ndc11 (package): 00409955869
rxcui: 1234995
spl id: 3e8928e4-d2cc-4fbe-89a0-f04e0f5e08f7
spl set id: cccd40ca-5f08-4acb-8548-3cad558388bb
unii: I65MW4OFHZ
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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