FDA.reportPublic FDA data

Polocaine-MPF

Product NDC
63323-260
11-digit product format
633230260
Labeler code
63323
Product ID
63323-260_b3d50315-0f09-4294-a788-990036dfc45c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Fresenius Kabi USA, LLC
Application
ANDA089406
Marketing category
ANDA
Marketing start
2009-07-20
Substance
MEPIVACAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polocaine-MPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012722, 1012726, 1012731, 1012735, 1012737, 1012741, 1866503, 1866515, 1866524, 1866531

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a6327eb-55be-3f7d-6c02-d7451033ded4Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339Product name120140508
d6039924-e573-fcdd-4fd1-ec85172a4599Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-260-01Polocaine-MPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION305
63323-260-37Polocaine-MPF25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-260-01ML - Milliliter63323-26040a49372-864f-4d22-8617-f519fe84d53312025-10-14
63323-260-30ML - Milliliter63323-2608a9ddf72-b4fd-4add-a1d3-ceaaa682801112012-07-24
63323-260-37ML - Milliliter63323-260e743c6a7-727d-4cb7-a2df-3ec1207da2bb12018-03-08

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-260POLOCAINE (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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1866503mepivacaine HCl 1 % in 30 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012722mepivacaine HCl 1 % Injectable SolutionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012731mepivacaine HCl 1.5 % in 30 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1866524mepivacaine HCl 2 % in 20 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012737mepivacaine HCl 2 % Injectable SolutionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1866515Polocaine 1 % in 30 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012726Polocaine 1 % Injectable SolutionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012735Polocaine 1.5 % in 30 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1866531Polocaine 2 % in 20 ML InjectionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
1012741Polocaine 2 % Injectable SolutionPSNa27d0815-ae6b-4a21-a8f5-564c01e838145
186653120 ML mepivacaine hydrochloride 20 MG/ML Injection [Polocaine]SBDa27d0815-ae6b-4a21-a8f5-564c01e838145
186651530 ML mepivacaine hydrochloride 10 MG/ML Injection [Polocaine]SBDa27d0815-ae6b-4a21-a8f5-564c01e838145
101273530 ML mepivacaine hydrochloride 15 MG/ML Injection [Polocaine]SBDa27d0815-ae6b-4a21-a8f5-564c01e838145
1012726mepivacaine hydrochloride 10 MG/ML Injectable Solution [Polocaine]SBDa27d0815-ae6b-4a21-a8f5-564c01e838145
1012741mepivacaine hydrochloride 20 MG/ML Injectable Solution [Polocaine]SBDa27d0815-ae6b-4a21-a8f5-564c01e838145
186652420 ML mepivacaine hydrochloride 20 MG/ML InjectionSCDa27d0815-ae6b-4a21-a8f5-564c01e838145
186650330 ML mepivacaine hydrochloride 10 MG/ML InjectionSCDa27d0815-ae6b-4a21-a8f5-564c01e838145
101273130 ML mepivacaine hydrochloride 15 MG/ML InjectionSCDa27d0815-ae6b-4a21-a8f5-564c01e838145
1012722mepivacaine hydrochloride 10 MG/ML Injectable SolutionSCDa27d0815-ae6b-4a21-a8f5-564c01e838145
1012737mepivacaine hydrochloride 20 MG/ML Injectable SolutionSCDa27d0815-ae6b-4a21-a8f5-564c01e838145
186653120 ML Polocaine 20 MG/ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
186651530 ML Polocaine 10 MG/ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
101273530 ML Polocaine 15 MG/ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1866503mepivacaine HCl 1 % per 30 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012731mepivacaine HCl 1.5 % per 30 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012737mepivacaine HCl 2 % Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1866524mepivacaine HCl 2 % per 20 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012722mepivacaine hydrochloride 1 % Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012726Polocaine 1 % Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1866515Polocaine 1 % per 30 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012735Polocaine 1.5 % per 30 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012726Polocaine 10 MG/ML Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012741Polocaine 2 % Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1866531Polocaine 2 % per 20 ML InjectionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1012741Polocaine 20 MG/ML Injectable SolutionSYa27d0815-ae6b-4a21-a8f5-564c01e838145
1866503mepivacaine HCl 1 % in 30 ML InjectionPSN996381e2-485b-9434-e053-2a95a90a08e14
186650330 ML mepivacaine hydrochloride 10 MG/ML InjectionSCD996381e2-485b-9434-e053-2a95a90a08e14
1866503mepivacaine HCl 1 % per 30 ML InjectionSY996381e2-485b-9434-e053-2a95a90a08e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-260-016332302600130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-260-376332302603725 VIAL, SINGLE-DOSE in 1 TRAY (63323-260-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-260-01) 2009-07-200000-00-00NoNoCurrent