Application 077250

Type: ANDA
Sponsor: SEPTODONT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	0.5%;0.0091MG/ML	No	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077250-001	VIVACAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP		2006-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP		2006-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077250-001	VIVACAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077250-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION		RS	2006-09-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A077250-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077250-001	AP	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Marcaine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Septodont, Inc.	3e196aa4-0b01-44db-9267-98a995b54743	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077250 application number: ANDA077250 ndc (product): 0362-0557
Vivacaine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Septodont, Inc.	b4c60d8e-e350-45b2-9d6b-5815eeb6c994	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077250 application number: ANDA077250 ndc (product): 0362-9011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0362-0557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-0557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate	Septodont, Inc.	ANDA	Current
31382-557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate	Carestream Health Inc.	ANDA	Current