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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0362-9011DDiscontinued by firm2026-08-17
excluded packagepackage0362-90110362-9011-10DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0362-9011-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0362-9011-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0362-9011-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0362-9011-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0362-9011-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0362-9011-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0362-9011-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0362-9011-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0362-9011-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0362-9011-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0362-9011-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0362-9011-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0362-9011-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0362-9011-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0362-9011-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0362-9011-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0362-9011-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0362-9011-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0362-9011-10IInactivated by FDA110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077250-001VIVACAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAP2006-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAP2006-09-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077250-001VIVACAINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077250-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONRS2006-09-27e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A077250-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077250-001AP1ea99ee380514…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AKA908P8J1Internal UNII lookup
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012461Internal RxNorm lookup
1670365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4c60d8e-e350-45b2-9d6b-5815eeb6c994Available on FDA.report

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#

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
bupivacaine hydrochlorideACTIVE INGREDIENT7TQO7W3VT8VIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
epinephrine bitartrateACTIVE INGREDIENT30Q7KI53AKVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
bupivacaineACTIVE MOIETYY8335394ROVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
epinephrineACTIVE MOIETYYKH834O4BHVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
sodium lactateINACTIVE INGREDIENTTU7HW0W0QTVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RVIVACAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]1

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MarcaineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont, Inc.3e196aa4-0b01-44db-9267-98a995b547432025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077250
application number: ANDA077250
VivacaineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont, Inc.b4c60d8e-e350-45b2-9d6b-5815eeb6c9942024-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077250
application number: ANDA077250
ndc (product): 0362-9011

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