NDC 63323-296-01 - POLOCAINE (MEPIVACAINE HCl)

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
63323-296
Requested NDC
63323-296-01
Package NDCs from labels
63323-296-01, 63323-296-57
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POLOCAINE (MEPIVACAINE HCl) - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL
Polocaine - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL
Polocaine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-10-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-296-01Polocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION505
63323-296-57Polocaine25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-296POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20221009_a27d0815-ae6b-4a21-a8f5-564c01e83814.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-296-01ML - Milliliter63323-296988022c0-13f4-496a-9f69-edb55a53fae212024-07-12
63323-296-50ML - Milliliter63323-296ccc8c3d2-ba48-4713-b5c2-f7b98615a07312012-07-24
63323-296-57ML - Milliliter63323-296c7b6178f-ed00-42db-9414-45a570dcf56b12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT4VFX2L7EM5POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
MEPIVACAINEACTIVE MOIETYB6E06QE59JPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]2

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 46 of 62 · 1,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
F22 SOMATICAAGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTAApex Energetics Inc.bed99bed-3902-5278-e053-2a95a90aeab62024-01-08WarningsExact identifier
unii: 451W47IQ8X
F27 MVONAGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bca69508-0934-ecfc-e053-2995a90a0ce32024-01-08WarningsExact identifier
unii: 451W47IQ8X
F26 PRSVRALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUMApex Energetics Inc.beaef254-bf57-df92-e053-2995a90abd652024-01-08WarningsExact identifier
unii: 451W47IQ8X
G05 OXI-METADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.beb18213-911a-38d4-e053-2a95a90ac17c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
LIVER PLUS FormulaADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.d8c7b349-8718-d8ed-e053-2995a90ae9882024-01-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC037ac04d-f8f3-4bb8-993a-ac8f7683ff832024-01-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEProficient Rx LPd0ce0bdf-5f24-4093-813f-881c61d7fcc72024-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAdare Pharmaceuticals Inc22edb0e6-4e45-4e91-aead-3581cca293a02023-12-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 451W47IQ8X
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5aa0adf8-7b84-4cb0-be31-5c3333a6cc442023-12-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5c4b0be5-625e-435f-9d2c-9d8fb407a8ea2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsd033c3b3-3ed6-4f23-a555-bae40cf0c48f2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.b501f7bc-fa3a-494e-bf95-6779a3169a492023-11-17WarningsExact identifier
unii: 660YQ98I10
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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