FDA.reportPublic FDA data

NDC 0143-9397-01 - Cisatracurium Besylate

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
0143-9397
Requested NDC
0143-9397-01
Package NDCs from labels
0143-9397-01, 0143-9397-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cisatracurium Besylate - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2025-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9397-01Cisatracurium Besylate10 mL in 1 VIALINJECTION105
0143-9397-10Cisatracurium Besylate10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9397CISATRACURIUM BESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20250516_46c815f6-7a3d-43a3-b470-3377b126ba09.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9397-01ML - Milliliter0143-9397f5bebb37-9b3e-4c1b-a1b5-0b51abb86eab12025-05-14
0143-9397-10ML - Milliliter0143-939738d481f0-b166-47ed-a1f6-ab44b69a4c3812025-05-14

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 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.c5a63679-0c94-4e9d-9ac0-8ee3023bd9a62025-05-15Warnings, Adverse reactionsExact identifier
unii: 80YS8O1MBS
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.46c815f6-7a3d-43a3-b470-3377b126ba092025-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA203079
ndc (package): 0143-9397-10
ndc (package): 0143-9397-01
ndc (product): 0143-9397
ndc11 (package): 00143939701
rxcui: 199211
spl id: cae2e417-a5d5-447b-a5ce-383f776b6d5e
spl set id: 46c815f6-7a3d-43a3-b470-3377b126ba09
unii: 80YS8O1MBS
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Cisatracurium besylateCISATRACURIUM BESYLATEGland Pharma Limited0bacc37a-5e7f-4f05-9206-56fc8041c1ad2025-04-04Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
CisatracuriumCISATRACURIUM BESYLATEFresenius Kabi USA, LLCf78a07e2-0d3b-4460-b29e-8c10c90afbda2025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Cisatracurium besylateCISATRACURIUM BESYLATECaplin Steriles Limited93101770-10a1-4bad-a762-289c793d8ace2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 199211
unii: 80YS8O1MBS

Reported adverse events (FAERS/openFDA)#

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