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 30 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
unii: 4550K0SC9B
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.8eb172da-dcd4-4660-4a8f-ad44a14b4af72024-11-06Adverse reactionsExact identifier
unii: 451W47IQ8X
Licefreee EverydaySODIUM CHLORIDETec Laboratories,Inc.407b5fd6-2331-2ba7-e054-00144ff88e882024-11-05WarningsExact identifier
unii: 451W47IQ8X
LicefreeeHEAD LICE TREATMENTTec Laboratories, Inc.08c9d3dd-7177-0148-e054-00144ff8d46c2024-11-05WarningsExact identifier
unii: 451W47IQ8X
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISMagni Company5d0db70c-6360-493b-bcf2-8dbc953141402024-11-05WarningsExact identifier
unii: 451W47IQ8X
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: 451W47IQ8X
Gluten DetoxBARLEY (GRAIN), CARBO VEGETABILIS, CINCHONA OFFICINALIS, GLUTEN, GLYPHOSATE, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PANCREAS SUIS, PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN)Liddell Laboratories, Inc.706f2e33-8674-4911-ba0a-4efc935e77392024-11-04WarningsExact identifier
unii: 451W47IQ8X
Derma PainCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Liddell Laboratories, Inc.e02a5e99-aa27-4276-a785-7b5328d89fdc2024-11-04WarningsExact identifier
unii: 451W47IQ8X
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: 451W47IQ8X
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: 451W47IQ8X
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.0ec09d62-07ca-4bbe-9019-1025f57132112024-10-31WarningsExact identifier
unii: 451W47IQ8X
Thyroid TonicACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUMEnergique, Inc.aeca8e0e-12e6-44d0-a709-401d137f7cf32024-10-31WarningsExact identifier
unii: 451W47IQ8X
SpleenparSPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUSEnergique, Inc.f89581c5-faab-42b2-b984-e369f6ff8b492024-10-30WarningsExact identifier
unii: 451W47IQ8X
Muscle/Tendon Pain and Stress ReliefCALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)Energique, Inc.4a8f73ab-77af-4556-8bf2-96b5f5d3fb8f2024-10-29WarningsExact identifier
unii: 451W47IQ8X
Nat MurNATRUM MURIATICUMEnergique, Inc.39c4cb25-e70f-4d5a-b7b6-1b62527aa4f32024-10-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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