FDA.reportPublic FDA data

NDC 63323-416-01 - 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
63323-416
Requested NDC
63323-416-01
Package NDCs from labels
63323-416-01, 63323-416-05
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
63323-416-01Cisatracurium5 mL in 1 VIALINJECTION, SOLUTION59
63323-416-05Cisatracurium10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-416CISATRACURIUM (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
63323-416-01ML - Milliliter63323-416a0e10ca9-d28b-45e3-9e90-989e2bf2cb6812025-08-11
63323-416-05ML - Milliliter63323-416843f3271-24f3-4718-b5b0-e42787448e4212015-08-04

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 1 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Cisatracurium BesylateCISATRACURIUM BESYLATEAvenacy, LLC1c6a8b98-deac-4e25-b4a0-5d0af50902812026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 199212
unii: 80YS8O1MBS
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
Cisatracurium BesylateCISATRACURIUM BESYLATEHospira, Inc.67908e20-044d-454d-9c51-bf106e817bd02026-05-25Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
rxcui: 199211
unii: 80YS8O1MBS
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: LKG8494WBH
Cisatracurium BesylateCISATRACURIUM BESYLATECamber Pharmaceuticals Inc.d8b5eb77-b393-4cd7-86c5-d2a9d131f96d2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
rxcui: 199211
unii: 80YS8O1MBS
Cisatracurium BesylateCISATRACURIUM BESYLATESomerset Therapeutics, LLC23daa1f8-2a07-449d-97a6-11efdb0b98362026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS
Cisatracurium BesylateCISATRACURIUM BESYLATESomerset Therapeutics, LLCed91f65b-e002-43bd-bfa0-5ce8b89119e62026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
unii: 80YS8O1MBS
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Cisatracurium BesylateCISATRACURIUM BESYLATEEugia US LLC2cb05c7e-6228-4e2d-a270-7659e3db3fa72025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199211
unii: 80YS8O1MBS
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.c5a63679-0c94-4e9d-9ac0-8ee3023bd9a62025-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
unii: 80YS8O1MBS
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.46c815f6-7a3d-43a3-b470-3377b126ba092025-05-15Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS
Cisatracurium besylateCISATRACURIUM BESYLATEGland Pharma Limited0bacc37a-5e7f-4f05-9206-56fc8041c1ad2025-04-04Warnings, Adverse reactionsExact identifier
rxcui: 1730194
rxcui: 199212
rxcui: 199211
unii: 80YS8O1MBS
CisatracuriumCISATRACURIUM BESYLATEFresenius Kabi USA, LLCf78a07e2-0d3b-4460-b29e-8c10c90afbda2025-02-21Warnings, Adverse reactionsExact identifier
application number: ANDA203183
application number: ANDA203182
ndc (package): 63323-417-10
ndc (package): 63323-416-01
ndc (package): 63323-417-01
ndc (package): 63323-418-01
ndc (package): 63323-418-20
ndc (package): 63323-416-05
ndc (product): 63323-418
ndc (product): 63323-417
ndc (product): 63323-416
ndc11 (package): 63323041601
rxcui: 1730194
rxcui: 199212
rxcui: 199211
spl id: 0431da49-a804-457c-a823-66d8862db3f2
spl set id: f78a07e2-0d3b-4460-b29e-8c10c90afbda
unii: 80YS8O1MBS

Reported adverse events (FAERS/openFDA)#

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