Carbocaine

Product NDC
0362-0753
11-digit product format
003620753
Labeler code
0362
Product ID
0362-0753_b544b6f7-b910-4980-a03c-51d98d7dc278
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mepivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont, Inc.
Application
ANDA088387
Marketing category
ANDA
Marketing start
2018-06-21
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
Carbocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012745, 1305263

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a6327eb-55be-3f7d-6c02-d7451033ded4Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
0362-0753-05Carbocaine5 in 1 CARTONINJECTION, SOLUTION55
0362-0753-05Carbocaine10 in 1 BLISTER PACKINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-0753-05ML - Milliliter0362-07534c3a0480-a193-411e-9605-47457550c65e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-0753CARBOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [SEPTODONT, INC.]5Current NDC, Legacy NDC, 2 package rows20240223_1f2f9e40-e437-4124-97b7-df67dbafd154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012745Carbocaine 3 % in 1.7 mL Dental CartridgePSN1f2f9e40-e437-4124-97b7-df67dbafd1545
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSN1f2f9e40-e437-4124-97b7-df67dbafd1545
10127451.7 ML mepivacaine hydrochloride 30 MG/ML Cartridge [Carbocaine]SBD1f2f9e40-e437-4124-97b7-df67dbafd1545
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCD1f2f9e40-e437-4124-97b7-df67dbafd1545
10127451.7 ML Carbocaine 30 MG/ML CartridgeSY1f2f9e40-e437-4124-97b7-df67dbafd1545
1012745Carbocaine 3 % 1.7 mL Dental CartridgeSY1f2f9e40-e437-4124-97b7-df67dbafd1545
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSY1f2f9e40-e437-4124-97b7-df67dbafd1545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-0753-05003620753055 BLISTER PACK in 1 CARTON (0362-0753-05) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE5 blister pack2018-06-210000-00-00NoNoCurrent