FDA.reportPublic FDA data

NDC 0143-9670-01 - Cefotetan

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
0143-9670
Requested NDC
0143-9670-01
Package NDCs from labels
0143-9670-01, 0143-9670-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefotetan for Injection , USP Rx onlyHikma Pharmaceuticals USA Inc.2024-04-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9670-01Cefotetan1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
0143-9670-10Cefotetan10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9670CEFOTETAN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240413_33b13b93-58ce-44c7-b9a2-af3b3a333f80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9670-01EA - Each0143-9670f33c1e87-bd07-4ed7-8d2c-b73ebd9d5c9012018-02-20
0143-9670-10EA - Each0143-96708ff80fe7-365f-429c-b2bf-43976a7397aa12018-02-20

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 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bridged Phenyl Combination 9312BRIDGED PHENYL COMBINATIONProfessional Complementary Health Formulas151c2748-a1dd-4406-a3d4-9d7baf98777d2026-01-08WarningsExact identifier
unii: 9NEZ333N27
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: 9NEZ333N27
JBA Collagen-Electrolyte MocktailVITAMIN C,THIAMIN,RIBOFLAVIN,NIACIN,VITAMIN B6,FOLATE,BIOTIN,PANTOTHENIC ACID,MAGNESIUM,ZINC,SODIUM,POTASSIUM,BOVINE COLLAGEN PEPTIDESAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse0199be5-0c51-411a-a184-225c1e6e602f2025-03-31WarningsExact identifier
unii: 9NEZ333N27
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
unii: 9NEZ333N27
CefotetanCEFOTETAN DISODIUMFresenius Kabi USA, LLCbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1722919
rxcui: 1722921
Trace Mineral CordALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM, PHOSPHORUS, PLATINUM, POTASSIUM, PRASEODYMIUM, RHENIUM, RHODIUM, RUBIDIUM, RUTHENIUM, SAMARIUM, SCANDIUM, SELENIUM, SILICON, SILVEREnergique, Inc.7a34327c-39fe-403b-87a0-4f3bea36bb2a2024-09-27WarningsExact identifier
unii: 9NEZ333N27
CefotetanCEFOTETANHikma Pharmaceuticals USA Inc.33b13b93-58ce-44c7-b9a2-af3b3a333f802024-04-11Warnings, Adverse reactionsExact identifier
application number: ANDA091031
ndc (package): 0143-9670-01
ndc (package): 0143-9671-10
ndc (package): 0143-9670-10
ndc (package): 0143-9671-01
ndc (product): 0143-9670
ndc (product): 0143-9671
ndc11 (package): 00143967001
rxcui: 1722919
rxcui: 1722921
spl id: 239c7e32-be35-41ea-b466-2e15d3339398
spl set id: 33b13b93-58ce-44c7-b9a2-af3b3a333f80
unii: 48SPP0PA9Q
CefotanCEFOTETANPAI Holdings, LLC dba PAI Pharmaf1510f5e-d001-44e0-accb-27cf79fd4f9a2024-04-08Warnings, Adverse reactionsExact identifier
rxcui: 1722919
rxcui: 1722921
PituistatARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUMEnergique, Inc.27a5fccb-8707-4bb5-a848-d1921bba2f7f2023-08-21WarningsExact identifier
unii: 9NEZ333N27
Met-ToxARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODESwHITE mANUFACTURING INC DBA MICRO-WESTe65db4c2-0bc7-4c50-8f18-b36ee004c4f52021-01-21WarningsExact identifier
unii: 9NEZ333N27

Reported adverse events (FAERS/openFDA)#

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