NDC 63323-294-01 - Polocaine

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
63323-294
Requested NDC
63323-294-01
Package NDCs from labels
63323-294-01, 63323-294-27
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2022-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Polocaine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-10-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-294-01Polocaine-MPF20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
63323-294-27Polocaine-MPF25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-294POLOCAINE (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
63323-294-01ML - Milliliter63323-294ffbc23f4-3877-4b3a-935d-83e5e93b539a12021-03-02
63323-294-20ML - Milliliter63323-294764678df-3057-4c14-bfbe-3e3d56298ccc12012-07-24
63323-294-27ML - Milliliter63323-29456e3897e-2eff-4322-9354-8c266a55a85d12018-03-08

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 43 of 61 · 1,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbocaineMEPIVACAINE HYDROCHLORIDESeptodont, Inc.1f2f9e40-e437-4124-97b7-df67dbafd1542024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
PolocaineMEPIVACAINE HYDROCHLORIDENovocol Pharmaceutical of Canada Inc.eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf2024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
MepivacaineMEPIVACAINE HYDROCHLORIDEBenco Dentalc9a5a849-d010-4637-a66a-c26176401fbd2024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
MepivacaineMEPIVACAINE HYDROCHLORIDENDC, Inc.042010fb-7161-4336-b91f-5a25839ee6442024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
MepivacaineMEPIVACAINE HYDROCHLORIDEPatterson Dental Supply, Inc.e8a3df4b-e918-4813-af3e-3c95f2c542502024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
PolocaineMEPIVACAINE HYDROCHLORIDEDentsply Pharmaceutical25074a6a-7f67-4ad8-86e0-2afe23ec5d042024-02-21Warnings, Adverse reactionsExact identifier
unii: 4VFX2L7EM5
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP61daa681-05a0-4b2f-a6d0-c6fc1044f5212024-02-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1043debe-8787-a2f5-e063-6294a90a2a662024-01-31WarningsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
unii: 660YQ98I10
TinnitusACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
unii: 660YQ98I10
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
POLOCAINE (MEPIVACAINE HCl)POLOCAINE (MEPIVACAINE HCL)HF Acquisition Co LLC, DBA HealthFirstc21a4c3a-82c0-0bfb-e053-2995a90a2b652024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA089407
rxcui: 1012722
unii: 4VFX2L7EM5
POLOCAINE (MEPIVACAINE HCl)POLOCAINE (MEPIVACAINE HCL)HF Acquisition Co LLC, DBA HealthFirstc20406a6-5611-59e4-e053-2995a90a3c8f2024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA089410
rxcui: 1012737
unii: 4VFX2L7EM5
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.fe08221d-74d5-490a-8db4-eaf3ed20b2892024-01-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POLOCAINE(R) -MPF (MEPIVACAINE HCI)POLOCAINE(R) -MPF (MEPIVACAINE HCI)HF Acquisition Co LLC, DBA HealthFirst996381e2-485b-9434-e053-2a95a90a08e12024-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA089406
rxcui: 1866503
unii: 4VFX2L7EM5
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst75c43df8-24f4-7f26-e053-2a91aa0aa21b2024-01-29Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
unii: M4I0D6VV5M
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst994a17da-4430-9489-e053-2a95a90acb7c2024-01-27Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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