Mepivacaine

Product NDC: 43128-005
11-digit product format: 431280005
Labeler code: 43128
Product ID: 43128-005_d65ce2b4-0c6a-4edd-bb95-c7f463db8dd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mepivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: NDC, Inc.
Application: ANDA088387
Marketing category: ANDA
Marketing start: 2015-04-10
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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088387-001	SCANDONEST PLAIN	MEPIVACAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION		RS	1984-10-10

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION		RS	1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088387-001	SCANDONEST PLAIN	3%	INJECTABLE / INJECTION	AP	RS	1984-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088387-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088387-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088387-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088387-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088387-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088387-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088387-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088387-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088387-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088387-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088387-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088387-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088387-001	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A088387-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088387-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088387-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088387-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088387-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088387-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEPIVACAINE HYDROCHLORIDE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4VFX2L7EM5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
042010fb-7161-4336-b91f-5a25839ee644	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
2a6327eb-55be-3f7d-6c02-d7451033ded4	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339	Product name	1	20140508
d6039924-e573-fcdd-4fd1-ec85172a4599	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43128-005-35	Mepivacaine	50 in 1 CARTON	injection, solution	50		6
43128-005-35	Mepivacaine	1.7 mL in 1 CARTRIDGE	injection, solution	1.7		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mepivacaine Hydrochloride	ACTIVE INGREDIENT	4VFX2L7EM5	MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NDC, INC.]	1
Mepivacaine	ACTIVE MOIETY	B6E06QE59J	MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NDC, INC.]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NDC, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NDC, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43128-005	MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NDC, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240223_042010fb-7161-4336-b91f-5a25839ee644.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scandonest 3% Plain	MEPIVACAINE HYDROCHLORIDE	Septodont, Inc.	af6ff5f6-7221-421b-9b7c-8fcee4a47772	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
MEPIVACAINE HYDROCHLORIDE	MEPIVACAINE HYDROCHLORIDE	Safco Dental Supply Co.	c4d45717-86c9-45bf-ba8e-2c255814ab50	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada, Inc.	f58cb2c7-22a6-4341-8f9a-85c5628af797	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Darby Dental Supply, LLC	5e81dae6-e55b-4d5e-9318-1d9395db052e	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine Hydrochloride	MEPIVACAINE HYDROCHLORIDE	Henry Schein Inc.	a3c2cddc-827b-4644-9060-e2fd2188b459	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Carbocaine	MEPIVACAINE HYDROCHLORIDE	Septodont, Inc.	1f2f9e40-e437-4124-97b7-df67dbafd154	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Polocaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada Inc.	eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Benco Dental	c9a5a849-d010-4637-a66a-c26176401fbd	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	NDC, Inc.	042010fb-7161-4336-b91f-5a25839ee644	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387 ndc (product): 43128-005
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Patterson Dental Supply, Inc.	e8a3df4b-e918-4813-af3e-3c95f2c54250	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387
Polocaine	MEPIVACAINE HYDROCHLORIDE	Dentsply Pharmaceutical	25074a6a-7f67-4ad8-86e0-2afe23ec5d04	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088387 application number: ANDA088387

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4VFX2L7EM5	MEPIVACAINE HYDROCHLORIDE	1722-62-9	MEPIVACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305263	mepivacaine HCl 3 % in 1.7 mL Dental Cartridge	PSN	042010fb-7161-4336-b91f-5a25839ee644	6
1305263	1.7 ML mepivacaine hydrochloride 30 MG/ML Cartridge	SCD	042010fb-7161-4336-b91f-5a25839ee644	6
1305263	mepivacaine HCl 3 % 1.7 ML Dental Cartridge	SY	042010fb-7161-4336-b91f-5a25839ee644	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43128-005-35	43128000535	50 CARTRIDGE in 1 CARTON (43128-005-35) / 1.7 mL in 1 CARTRIDGE	50 cartridge	2015-04-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mepivacaine HCl 3% (30 mg/mL) (Mepivacaine Hydrochloride Injection, USP)	NDC, Inc. \| Novocol Pharmaceutical of Canada, Inc.	2024-02-21	HUMAN PRESCRIPTION DRUG LABEL	6