FDA.reportPublic FDA data

NDC 0409-4208-01 - Marcaine with Epinephrine

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
0409-4208
Requested NDC
0409-4208-01
Package NDCs from labels
0409-4208-01, 0409-4208-10
Manufacturer
Hospira, Inc. | Standard Chem. & Pharm. Co., Ltd. Plant II
Effective date
2024-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPIVACAINE - Hospira, Inc. | Standard Chem. & Pharm. Co., Ltd. Plant IIHospira, Inc. | Standard Chem. & Pharm. Co., Ltd. Plant II2024-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4208-01Marcaine with Epinephrine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION305
0409-4208-10Marcaine with Epinephrine10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4208MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, Legacy NDC, 2 package rows20240203_93cf0914-de08-4ec6-8f8c-d663243b9958.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4208-01ML - Milliliter0409-4208f1afe1b3-094a-438c-84d2-4137aed23fa412022-10-06
0409-4208-10ML - Milliliter0409-420839d1d1bb-7bad-4e7b-91ee-a237f436ced712022-10-06

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 43 of 68 · 1,355 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: 451W47IQ8X
CV HPADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),ENERGIQUE, INC.c06763c5-8bde-4251-bd41-67becf8ce8c42024-10-24WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.2af0dc7b-5f8b-44fa-9589-bc95043428e92024-10-24WarningsExact identifier
unii: 451W47IQ8X
Septocaine and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont Inc.0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce032024-10-23Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: 451W47IQ8X
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: 451W47IQ8X
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 451W47IQ8X
unii: PQ6CK8PD0R
RhustoxoforceAPIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICABioActive Nutritional, Inc.5a3627f1-a850-42f3-8c7a-b2067bd035382024-10-18WarningsExact identifier
unii: 451W47IQ8X
MetabolismBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.76f70259-44b1-467a-bff4-b427ddfe3abd2024-10-17WarningsExact identifier
unii: PQ6CK8PD0R
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
unii: 451W47IQ8X
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
unii: 451W47IQ8X
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1672919
rxcui: 1672917
unii: 30Q7KI53AK
unii: 7TQO7W3VT8
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCe5e325d1-0d58-40c9-9645-3ae402ff9d922024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PrenatrylFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb364551b-2ccc-4db3-e053-2995a90afbbf2024-10-08Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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