Mepivacaine

Product NDC
66975-406
11-digit product format
669750406
Labeler code
66975
Product ID
66975-406_d21c27b5-f8f3-4f4e-bd9e-e1398a12ecfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mepivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Benco Dental
Application
ANDA088387
Marketing category
ANDA
Marketing start
2011-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
66975-406-51Mepivacaine10 in 1 BLISTER PACKINJECTION, SOLUTION106
66975-406-51Mepivacaine5 in 1 CARTONINJECTION, SOLUTION56

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevonordefrinACTIVE INGREDIENTV008L6478DMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Mepivacaine HydrochlorideACTIVE INGREDIENT4VFX2L7EM5MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
LevonordefrinACTIVE MOIETYV008L6478DMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
MepivacaineACTIVE MOIETYB6E06QE59JMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Potassium metabisulfiteINACTIVE INGREDIENT65OE787Q7WMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1
WaterINACTIVE INGREDIENT059QF0KO0RMEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MEPIVACAINE WITH LEVONORDEFRIN (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN) INJECTION, SOLUTION [BENCO DENTAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-406MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [BENCO DENTAL]6Current NDC, Legacy NDC, 2 package rows20240223_c9a5a849-d010-4637-a66a-c26176401fbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSNc9a5a849-d010-4637-a66a-c26176401fbd6
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCDc9a5a849-d010-4637-a66a-c26176401fbd6
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSYc9a5a849-d010-4637-a66a-c26176401fbd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-406-51669750406515 BLISTER PACK in 1 CARTON (66975-406-51) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE5 blister pack2011-01-010000-00-00NoNoCurrent