Mepivacaine

Product NDC
51004-0005
11-digit product format
510040005
Labeler code
51004
Product ID
51004-0005_7763e9e4-e902-4cf2-9cc9-cc233f4d038d
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
2015-04-10
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
Mepivacaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1305263

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
51004-0005-3Mepivacaine1.7 mL in 1 CARTRIDGEinjection, solution1.71
51004-0005-3Mepivacaine50 in 1 CARTONinjection, solution501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSNf58cb2c7-22a6-4341-8f9a-85c5628af7971
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCDf58cb2c7-22a6-4341-8f9a-85c5628af7971
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSYf58cb2c7-22a6-4341-8f9a-85c5628af7971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51004-0005-35100400050350 CARTRIDGE in 1 CARTON (51004-0005-3) / 1.7 mL in 1 CARTRIDGE50 cartridge2015-04-10NoNoCurrent