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 47 of 47 · 923 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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