Application 088387

Type: ANDA
Sponsor: DEPROCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SCANDONEST PLAIN	MEPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	3%	No	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…`

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 ndc (product): 0362-1098
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 ndc (product): 67239-0201
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 ndc (product): 66467-9760
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 ndc (product): 0404-6730
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 ndc (product): 0362-0753
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 ndc (product): 66975-406
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 ndc (product): 50227-1080
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 ndc (product): 66312-441

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0362-0753	Carbocaine	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0362-0753	Carbocaine	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0362-0753	Carbocaine	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0362-1098	Scandonest 3% Plain	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0362-1098	Scandonest 3% Plain	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0362-1098	Scandonest 3% Plain	Mepivacaine Hydrochloride	Septodont, Inc.	ANDA	Current
0404-6730	Mepivacaine Hydrochloride	Mepivacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-6730	Mepivacaine Hydrochloride	Mepivacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-6730	Mepivacaine Hydrochloride	Mepivacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-6730	Mepivacaine Hydrochloride	Mepivacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
0404-6730	Mepivacaine Hydrochloride	Mepivacaine Hydrochloride	Henry Schein Inc.	ANDA	Current
31382-753	Carbocaine	Mepivacaine hydrochloride	Caresteam Health, Inc.	ANDA	Current
42756-1080	IQ Dental Mepivacaine	Mepivacaine Hydrochloride	IQ Dental	ANDA	Current
42756-1080	IQ Dental Mepivacaine	Mepivacaine Hydrochloride	IQ Dental	ANDA	Current
42756-1080	IQ Dental Mepivacaine	Mepivacaine Hydrochloride	IQ Dental	ANDA	Current
43128-005	Mepivacaine	Mepivacaine Hydrochloride	NDC, Inc.	ANDA	Current
43128-005	Mepivacaine	Mepivacaine Hydrochloride	NDC, Inc.	ANDA	Current
43128-005	Mepivacaine	Mepivacaine Hydrochloride	NDC, Inc.	ANDA	Current
43305-1080	Pearson Mepivacaine	Mepivacaine Hydrochloride	Pearson Dental	ANDA	Current
50227-1080	Mepivacaine	Mepivacaine Hydrochloride	Patterson Dental Supply, Inc.	ANDA	Current
50227-1080	Mepivacaine	Mepivacaine Hydrochloride	Patterson Dental Supply, Inc.	ANDA	Current
50227-1080	Mepivacaine	Mepivacaine Hydrochloride	Patterson Dental Supply, Inc.	ANDA	Current
51004-0053	Mepivacaine	Mepivacaine Hydrochloride	Novocol Pharmaceutical of Canada, Inc.	ANDA	Current
51004-1098	Scandonest Plain	Mepivacaine Hydrochloride	Novocol Pharmaceutical of Canada, Inc.	ANDA	Current
51004-2020	Isocaine	Mepivacaine Hydrochloride	Novocol Pharmaceutical of Canada, Inc.	ANDA	Current
66312-441	Polocaine	Mepivacaine Hydrochloride	Dentsply Pharmaceutical	ANDA	Current
66312-441	Polocaine	Mepivacaine Hydrochloride	Dentsply Pharmaceutical	ANDA	Current
66312-441	Polocaine	Mepivacaine Hydrochloride	Dentsply Pharmaceutical	ANDA	Current
66312-441	Polocaine	Mepivacaine Hydrochloride	Dentsply Pharmaceutical	ANDA	Current
66467-9760	Mepivacaine	Mepivacaine Hydrochloride	Darby Dental Supply, LLC	ANDA	Current
66467-9760	Mepivacaine	Mepivacaine Hydrochloride	Darby Dental Supply, LLC	ANDA	Current
66467-9760	Mepivacaine	Mepivacaine Hydrochloride	Darby Dental Supply, LLC	ANDA	Current
66975-406	Mepivacaine	Mepivacaine Hydrochloride	Benco Dental	ANDA	Current
66975-406	Mepivacaine	Mepivacaine Hydrochloride	Benco Dental	ANDA	Current
66975-406	Mepivacaine	Mepivacaine Hydrochloride	Benco Dental	ANDA	Current
67239-0201	MEPIVACAINE HYDROCHLORIDE	Mepivacaine Hydrochloride	Safco Dental Supply Co.	ANDA	Current
67239-0201	MEPIVACAINE HYDROCHLORIDE	Mepivacaine Hydrochloride	Safco Dental Supply Co.	ANDA	Current
67239-0201	MEPIVACAINE HYDROCHLORIDE	Mepivacaine Hydrochloride	Safco Dental Supply Co.	ANDA	Current
67239-0201	MEPIVACAINE HYDROCHLORIDE	Mepivacaine Hydrochloride	Safco Dental Supply Co.	ANDA	Current