FDA.reportPublic FDA data

NDC 63323-417-01 - Cisatracurium

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
63323-417
Requested NDC
63323-417-01
Package NDCs from labels
63323-417-01, 63323-417-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-02-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cisatracurium - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-02-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-417-01Cisatracurium10 mL in 1 VIALINJECTION, SOLUTION109
63323-417-10Cisatracurium10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-417CISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20250323_f78a07e2-0d3b-4460-b29e-8c10c90afbda.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-417-01ML - Milliliter63323-41755b2e8a6-e2c4-49c3-b795-248433bb215c12025-08-11
63323-417-10ML - Milliliter63323-417d86385ba-023e-4fae-bc2f-e2e60e63509312015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CISATRACURIUM BESYLATEACTIVE INGREDIENT80YS8O1MBSCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CISATRACURIUMACTIVE MOIETYQX62KLI41NCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18ACISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCISATRACURIUM (CISATRACURIUM BESYLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cisatracurium besylateCISATRACURIUM BESYLATECaplin Steriles Limited93101770-10a1-4bad-a762-289c793d8ace2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
rxcui: 199211
unii: 80YS8O1MBS
Cisatracurium BesylateCISATRACURIUM BESYLATEArmas Pharmaceuticalsdd078343-1f43-4405-8048-cf6c4f4565492025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 199212
unii: 80YS8O1MBS
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc2ee0358e-2cce-40d3-9fcf-1b9088815c982024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc291a55dd-ab45-4660-b513-4ecb729eb0512024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
unii: 80YS8O1MBS
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
Cisatracurium besylateCISATRACURIUM BESYLATESlate Run Pharmaceuticals, LLC49185e78-d244-4426-90ef-ad109824eddb2024-08-29Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
unii: 80YS8O1MBS
cisatracurium besylateCISATRACURIUM BESYLATEZydus Pharmaceuticals USA Inc.f9e1a84b-d19e-46c5-b40f-944ac1543dac2024-08-16Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
unii: 80YS8O1MBS
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
Cisatracurium besylateCISATRACURIUM BESYLATESlate Run Pharmaceuticals, LLCe06c4d57-bfc7-45ad-b1cd-b5b88dc43b502024-03-25Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS

Reported adverse events (FAERS/openFDA)#

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