FDA.reportPublic FDA data

Mepivacaine Hydrochloride

Product NDC
0404-6730
11-digit product format
004046730
Labeler code
0404
Product ID
0404-6730_9560ee92-fbdd-410a-848d-7314839c116b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mepivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Henry Schein Inc.
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 Hydrochloride
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-6730-302021-11-02C16284748780-19d75b9d0-348d-f424-e053-dadaa90a57ce88fe7832-39a8-4fed-8c96-89df83d8ee11
0404-6730-302020-01-31C16284748780-19d75b9d0-348d-f424-e053-dadaa90a57ce88fe7832-39a8-4fed-8c96-89df83d8ee11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-6730-05Mepivacaine Hydrochloride10 in 1 BLISTER PACKINJECTION, SOLUTION109
0404-6730-05Mepivacaine Hydrochloride5 in 1 CARTONINJECTION, SOLUTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0404-6730-05ML - Milliliter0404-6730ebf0c6ed-ca1f-42e2-b010-2f3df281ac3e12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-6730MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN INC.]9Current NDC, Legacy NDC, 2 package rows20240223_a3c2cddc-827b-4644-9060-e2fd2188b459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSNa3c2cddc-827b-4644-9060-e2fd2188b4599
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCDa3c2cddc-827b-4644-9060-e2fd2188b4599
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSYa3c2cddc-827b-4644-9060-e2fd2188b4599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-6730-05004046730055 BLISTER PACK in 1 CARTON (0404-6730-05) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE5 blister pack2011-01-010000-00-00NoNoCurrent