Marcaine

Product NDC: 31382-557
11-digit product format: 313820557
Labeler code: 31382
Product ID: 31382-557_de328af3-2345-40cd-a393-ab91adc5c9a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupivacaine hydrochloride and epinephrine bitartrate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Carestream Health Inc.
Application: ANDA077250
Marketing category: ANDA
Marketing start: 2013-06-01
Marketing end: 0000-00-00
Substance: BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength: 5 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	31382-557		D	Discontinued by firm		2026-08-17
excluded package	package	31382-557	31382-557-05	D	Discontinued by firm		2026-08-17

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31382-557-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31382-557-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31382-557-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31382-557-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31382-557-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31382-557-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31382-557-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31382-557-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31382-557-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31382-557-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31382-557-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31382-557-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31382-557-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31382-557-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31382-557-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	31382-557-05	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	31382-557-05	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	31382-557-05	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	31382-557-05	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	31382-557-05	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	31382-557-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	31382-557-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
31382-557-05	2024-12-20	C162847	48780-1	9d75b9d0-96f1-f424-e053-dadaa90a57ce	Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate) (bupivacaine hydrochloride and epinephrine injection, USP)
31382-557-05	2020-01-31	C162847	48780-1	9d75b9d0-96f1-f424-e053-dadaa90a57ce	Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate) (bupivacaine hydrochloride and epinephrine injection, USP)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31382-557-05	ML - Milliliter	31382-557	05337cc0-9d7a-4612-b6d6-b6867036c89f	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	AKA908P8J1	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
epinephrine bitartrate	ACTIVE INGREDIENT	30Q7KI53AK	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
epinephrine	ACTIVE MOIETY	YKH834O4BH	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
monothioglycerol	INACTIVE INGREDIENT	AAO1P0WSXJ	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
sodium lactate	INACTIVE INGREDIENT	TU7HW0W0QT	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH INC.]	2

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AKA908P8J1	BUPIVACAINE HYDROCHLORIDE ANHYDROUS	18010-40-7	BUPIVACAINE HYDROCHLORIDE ANHYDROUS
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate) (bupivacaine hydrochloride and epinephrine injection, USP)	Carestream Health Inc. \| Novocol Pharmaceutical of Canada, Inc.	2013-06-01	HUMAN PRESCRIPTION DRUG LABEL	2