FDA.reportPublic FDA data

Vivacaine

Product NDC
0362-9011
11-digit product format
003629011
Labeler code
0362
Product ID
0362-9011_a427016b-7421-413c-85fc-64f583ebe336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride and epinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont, Inc.
Application
ANDA077250
Marketing category
ANDA
Marketing start
2013-06-01
Substance
BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength
5; .005 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS5 mg/mL
EPINEPHRINE BITARTRATE.005 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAKA908P8J1, 30Q7KI53AK
Rxcui1012461, 1670365

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0362-9011-102023-11-21C16284748780-1956f9ecf-d9a7-621f-e053-dbdaa90a74ad7257e8e4-9007-408c-9a9b-109bdd1d6d1e
0362-9011-102019-10-21C16284748780-1956f9ecf-d9a7-621f-e053-dbdaa90a74ad7257e8e4-9007-408c-9a9b-109bdd1d6d1e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-9011-50Vivacaine1.8 mL in 1 CARTRIDGEINJECTION, SOLUTION1.811
0362-9011-50Vivacaine50 in 1 CARTONINJECTION, SOLUTION5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-9011-50ML - Milliliter0362-90113fdbef12-8774-4536-89cb-f59042badf9b12019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTAKA908P8J1VIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
epinephrine bitartrateACTIVE INGREDIENT30Q7KI53AKVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
BUPIVACAINEACTIVE MOIETYY8335394ROVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
epinephrineACTIVE MOIETYYKH834O4BHVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
monothioglycerolINACTIVE INGREDIENTAAO1P0WSXJVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
sodium lactateINACTIVE INGREDIENTTU7HW0W0QTVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-9011VIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]11Current NDC, Legacy NDC, 2 package rows20240217_b4c60d8e-e350-45b2-9d6b-5815eeb6c994.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670365BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental CartridgePSNb4c60d8e-e350-45b2-9d6b-5815eeb6c99411
1012461Vivacaine 5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental CartridgePSNb4c60d8e-e350-45b2-9d6b-5815eeb6c99411
10124611.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]SBDb4c60d8e-e350-45b2-9d6b-5815eeb6c99411
16703651.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML CartridgeSCDb4c60d8e-e350-45b2-9d6b-5815eeb6c99411
1670365bupivacaine HCl 0.5 % / epinephrine 1:200,000 per 1.8 ML Dental CartridgeSYb4c60d8e-e350-45b2-9d6b-5815eeb6c99411
1012461Vivacaine (bupivacaine HCl 5 % / epinephrine (as epinephrine bitartrate) 1:200,000) in 1.8 mL CartridgeSYb4c60d8e-e350-45b2-9d6b-5815eeb6c99411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-9011-500036290115050 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE50 cartridge2013-06-010000-00-00NoNoCurrent