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 61 of 61 · 1,205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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