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 27 of 62 · 1,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd0b21c366-fff6-4754-a671-35481ec2c4bd2025-07-07WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Schuessler Tissue Salts Kali Mur Glandular Tonic 5KALI MURIATICUMMartin & Pleasance Pty Ltd4b2d8d03-c829-4292-ad94-993376d81b8f2025-07-01WarningsExact identifier
unii: 660YQ98I10
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packagingb165ad93-1dc1-4863-9f0b-d7b97c42c94c2025-06-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Calcium ChlorideCALCIUM CHLORIDE INJECTIONMedefil, Inc.90b8936e-61f2-5318-e053-2995a90aac442025-06-17Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Potassium Chloride ERPOTASSIUM CHLORIDE ERDirect_Rx377854ff-8034-c7ac-e063-6294a90a08172025-06-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
Scandonest 3% PlainMEPIVACAINE HYDROCHLORIDESeptodont, Inc.af6ff5f6-7221-421b-9b7c-8fcee4a477722025-05-29Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.d397ed9c-10f0-4a99-baca-a31e5e18572a2025-05-27WarningsExact identifier
unii: 451W47IQ8X
VirimmuneACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUMDeseret Biologicals, Inc.1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d42025-05-27WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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