Application 012250

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	Yes	Yes
002	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	Yes
005	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N012250-001	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N012250-002	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N012250-005	CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012250-005	CARBOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012250-001	CARBOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012250-002	CARBOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012250-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012250-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012250-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012250-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012250-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012250-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012250-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012250-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012250-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012250-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012250-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012250-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012250-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012250-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012250-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012250-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012250-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012250-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012250-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012250-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012250-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012250-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012250-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012250-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012250-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012250-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012250-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012250-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012250-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012250-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012250-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012250-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012250-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012250-001	AP	1	`4b0b4de00fa7…`

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 · 12 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	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE	MEPIVACAINE HYDROCHLORIDE	Safco Dental Supply Co.	c4d45717-86c9-45bf-ba8e-2c255814ab50	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada, Inc.	f58cb2c7-22a6-4341-8f9a-85c5628af797	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Darby Dental Supply, LLC	5e81dae6-e55b-4d5e-9318-1d9395db052e	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine Hydrochloride	MEPIVACAINE HYDROCHLORIDE	Henry Schein Inc.	a3c2cddc-827b-4644-9060-e2fd2188b459	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Carbocaine	MEPIVACAINE HYDROCHLORIDE	Septodont, Inc.	1f2f9e40-e437-4124-97b7-df67dbafd154	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Carbocaine generic name: MEPIVACAINE HYDROCHLORIDE
Polocaine	MEPIVACAINE HYDROCHLORIDE	Novocol Pharmaceutical of Canada Inc.	eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Benco Dental	c9a5a849-d010-4637-a66a-c26176401fbd	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	NDC, Inc.	042010fb-7161-4336-b91f-5a25839ee644	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine	MEPIVACAINE HYDROCHLORIDE	Patterson Dental Supply, Inc.	e8a3df4b-e918-4813-af3e-3c95f2c54250	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Polocaine	MEPIVACAINE HYDROCHLORIDE	Dentsply Pharmaceutical	25074a6a-7f67-4ad8-86e0-2afe23ec5d04	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE
Polocaine-MPF	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a27d0815-ae6b-4a21-a8f5-564c01e83814	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: MEPIVACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1036	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1036	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1036	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1036	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1036	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1038	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1041	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1041	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1041	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1041	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1041	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1067	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1067	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1067	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1067	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-1067	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-2047	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-2047	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-2047	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-2047	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current
0409-2047	Carbocaine	Mepivacaine Hydrochloride	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77112	SUPPL	2023-12-26
77114	SUPPL	2023-12-22
56319	SUPPL	2018-11-06
56258	SUPPL	2018-11-05
33079	SUPPL	2010-02-25
314	SUPPL	2010-02-25
11995	SUPPL	2005-10-20
10799	SUPPL	2005-09-30