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 54 of 65 · 1,297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLC3335dabe-66d5-440b-a59a-b62993030e0f2023-06-09Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCf29c905e-9a55-446f-a89d-860ad9ade7ad2023-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC694926ac-aff0-aa1f-e053-2991aa0a95882023-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6a9bf-f7cb-035a-e053-2a95a90a6a3d2023-05-03Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd1642239-4230-b679-e053-2a95a90a3b7c2023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1012384
rxcui: 1867596
rxcui: 1012377
rxcui: 1867594
unii: 30Q7KI53AK
unii: 7TQO7W3VT8
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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