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 49 of 68 · 1,355 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: 451W47IQ8X
unii: PQ6CK8PD0R
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.fc908011-5e5e-459a-a666-d414265047032024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ZorcaineARTICAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.1767d606-69b8-419e-840f-36550ed91b8f2024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental2b5a7ee3-71ee-4c41-ad9f-852f170470b32024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.0b0cbbec-8216-434f-892e-226c89d7239c2024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.cc7ff594-2204-44b2-8f81-bcb9c7e9360b2024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.f26a084b-ab25-4ca2-8f58-705a4219bf322024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental406de6e6-40f5-44c5-a109-3be0b9d48e582024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df2024-03-06Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
VirimmuneALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2022-2023), MORBILLINUMDeseret Biologicals, Inc.ce3962de-576a-49f6-8dc3-68ba7ad96e9f2024-03-05WarningsExact identifier
unii: 451W47IQ8X
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: QTT17582CB
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: 451W47IQ8X
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dentald47d7842-930e-41db-9631-d1aba0f05ae02024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINEHenry Scheind9402ac2-fedd-4fb0-90a3-2c466a7865262024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ArticadentARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical9ca8fb43-4f34-47c0-8b79-3b5bd1eaee002024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.c4bba4ab-2b20-43e6-92ea-9ec6f1fce7542024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.854399ec-f7d6-4eab-87bb-94c2b442ec3e2024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dental4524cb96-40f7-471f-bfc6-1dcab47628ec2024-03-01Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Citanest Forte DENTALPRILOCAINE HCL AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.801a4f80-397b-46c5-ad3e-a80594e7bda22024-02-29Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK

Reported adverse events (FAERS/openFDA)#

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