Polocaine

Product NDC
51004-4411
11-digit product format
510044411
Labeler code
51004
Product ID
51004-4411_c0be08fc-d144-437c-9890-fa29b33eb3fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mepivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Novocol Pharmaceutical of Canada Inc.
Application
ANDA088387
Marketing category
ANDA
Marketing start
1984-10-10
Substance
MEPIVACAINE HYDROCHLORIDE
Active strength
30 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012756, 1305263

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a6327eb-55be-3f7d-6c02-d7451033ded4Product name120140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339Product name120140508
d6039924-e573-fcdd-4fd1-ec85172a4599Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51004-4411-6Polocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71
51004-4411-6Polocaine50 in 1 CARTONINJECTION, SOLUTION501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSNeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
1012756Polocaine 3 % in 1.7 mL Dental CartridgePSNeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
10127561.7 ML mepivacaine hydrochloride 30 MG/ML Cartridge [Polocaine]SBDeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCDeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
10127561.7 ML Polocaine 30 MG/ML CartridgeSYeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSYeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1
1012756Polocaine 3 % 1.7 ML Dental CartridgeSYeb7e2284-fe8d-46ad-b1d3-92ee2c6222bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51004-4411-65100444110650 CARTRIDGE in 1 CARTON (51004-4411-6) / 1.7 mL in 1 CARTRIDGE50 cartridge1984-10-10NoNoCurrent