Scandonest 3% Plain

Product NDC
0362-1098
11-digit product format
003621098
Labeler code
0362
Product ID
0362-1098_104f9a5f-ec7b-4caa-b357-ff7cc18cfc90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mepivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Septodont, Inc.
Application
ANDA088387
Marketing category
ANDA
Marketing start
2017-12-22
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
Scandonest 3% Plain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPIVACAINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4VFX2L7EM5
Rxcui1012762, 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
0362-1098-90Scandonest 3% Plain10 in 1 BLISTER PACKinjection, solution106
0362-1098-90Scandonest 3% Plain5 in 1 CARTONinjection, solution56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-1098SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [SEPTODONT, INC.]5Current NDC, Legacy NDC, 2 package rows20240223_af6ff5f6-7221-421b-9b7c-8fcee4a47772.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305263mepivacaine HCl 3 % in 1.7 mL Dental CartridgePSNaf6ff5f6-7221-421b-9b7c-8fcee4a477726
1012762Scandonest 3 % in 1.7 mL Dental CartridgePSNaf6ff5f6-7221-421b-9b7c-8fcee4a477726
10127621.7 ML mepivacaine hydrochloride 30 MG/ML Cartridge [Scandonest]SBDaf6ff5f6-7221-421b-9b7c-8fcee4a477726
13052631.7 ML mepivacaine hydrochloride 30 MG/ML CartridgeSCDaf6ff5f6-7221-421b-9b7c-8fcee4a477726
10127621.7 ML Scandonest 30 MG/ML CartridgeSYaf6ff5f6-7221-421b-9b7c-8fcee4a477726
1305263mepivacaine HCl 3 % 1.7 ML Dental CartridgeSYaf6ff5f6-7221-421b-9b7c-8fcee4a477726
1012762Scandonest 3 % 1.7 ML Dental CartridgeSYaf6ff5f6-7221-421b-9b7c-8fcee4a477726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-1098-90003621098905 BLISTER PACK in 1 CARTON (0362-1098-90) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE5 blister pack2017-12-220000-00-00NoNoCurrent