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

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 productproduct0404-6730DDiscontinued by firm2026-08-03
excluded packagepackage0404-67300404-6730-30DDiscontinued by firm2026-08-03

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 · 30 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued 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 packagepackage0404-6730-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0404-6730-30IInactivated 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 packagepackage0404-6730-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0404-6730-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A088387-001SCANDONEST PLAINMEPIVACAINE HYDROCHLORIDE3%INJECTABLE / INJECTIONRS1984-10-10

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-103f01610625f2…
2019-09-15 20:21 UTC2019-09A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONRS1984-10-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088387-001SCANDONEST PLAIN3%INJECTABLE / INJECTIONAPRS1984-10-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088387-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088387-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088387-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088387-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088387-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088387-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088387-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088387-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088387-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088387-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088387-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088387-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088387-001AP1ea99ee380514…
2023-05-13 08:27 UTC2023-05A088387-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088387-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088387-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088387-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088387-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088387-001AP1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4VFX2L7EM5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1305263Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3c2cddc-827b-4644-9060-e2fd2188b459Available on FDA.report

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#

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

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scandonest 3% PlainMEPIVACAINE HYDROCHLORIDESeptodont, Inc.af6ff5f6-7221-421b-9b7c-8fcee4a477722025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MEPIVACAINE HYDROCHLORIDEMEPIVACAINE HYDROCHLORIDESafco Dental Supply Co.c4d45717-86c9-45bf-ba8e-2c255814ab502024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MepivacaineMEPIVACAINE HYDROCHLORIDENovocol Pharmaceutical of Canada, Inc.f58cb2c7-22a6-4341-8f9a-85c5628af7972024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MepivacaineMEPIVACAINE HYDROCHLORIDEDarby Dental Supply, LLC5e81dae6-e55b-4d5e-9318-1d9395db052e2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
Mepivacaine HydrochlorideMEPIVACAINE HYDROCHLORIDEHenry Schein Inc.a3c2cddc-827b-4644-9060-e2fd2188b4592024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
ndc (product): 0404-6730
CarbocaineMEPIVACAINE HYDROCHLORIDESeptodont, Inc.1f2f9e40-e437-4124-97b7-df67dbafd1542024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
PolocaineMEPIVACAINE HYDROCHLORIDENovocol Pharmaceutical of Canada Inc.eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MepivacaineMEPIVACAINE HYDROCHLORIDEBenco Dentalc9a5a849-d010-4637-a66a-c26176401fbd2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MepivacaineMEPIVACAINE HYDROCHLORIDENDC, Inc.042010fb-7161-4336-b91f-5a25839ee6442024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
MepivacaineMEPIVACAINE HYDROCHLORIDEPatterson Dental Supply, Inc.e8a3df4b-e918-4813-af3e-3c95f2c542502024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387
PolocaineMEPIVACAINE HYDROCHLORIDEDentsply Pharmaceutical25074a6a-7f67-4ad8-86e0-2afe23ec5d042024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088387
application number: ANDA088387

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