MARCAINE WITH EPINEPHRINE

Product NDC: 52584-746
11-digit product format: 525840746
Labeler code: 52584
Product ID: 52584-746_a9a9167b-23e6-44bd-90b1-c78ad41e0812
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupivacaine hydrochloride and epinephrine bitartrate
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: General Injectables & Vaccines, Inc.
Application: NDA016964
Marketing category: NDA
Marketing start: 2019-11-04
Marketing end: 0000-00-00
Substance: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 3 mg/mL; mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	52584-746		D	Discontinued by firm		2026-10-05
excluded package	package	52584-746	52584-746-71	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-746-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-746-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-746-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-746-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-746-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-746-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-746-71	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-746-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-746-71	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-746-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-746-71	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-746-71	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016964-001	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-006	MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 10 matching rows.

Application-product, TE code table
Application-product	TE code
N016964-001	AP
N016964-004	AP
N016964-005	AP
N016964-006	AP
N016964-007	AP
N016964-008	AP
N016964-009	AP
N016964-010	AP
N016964-012	AP
N016964-013	AP

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 11 · 430 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
2026-09-14 22:38:34	2026-08	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 430 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N016964-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-009	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-010	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-012	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016964-013	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016964-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-012	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016964-013	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016964-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-012	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016964-013	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-009	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-012	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016964-013	AP	1	`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

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

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	562f4499-f3b7-4d9e-b022-61172176c883	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	67578b56-7540-487e-1fba-481255620e78	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
MARCAINE WITH EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein, Inc.	d0d51133-882c-4f9e-ba1c-f037226305a1	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine	BUPIVACINE HYDROCHLORIDE	Henry Schein, Inc.	7d94e8e0-0d1e-4af3-973a-a480d7d51737	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964
Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	93cf0914-de08-4ec6-8f8c-d663243b9958	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016964 application number: NDA016964

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE	73360-54-0	BUPIVACAINE HYDROCHLORIDE
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-746-71	52584074671	1 VIAL, SINGLE-DOSE in 1 BAG (52584-746-71) > 30 mL in 1 VIAL, SINGLE-DOSE	2019-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MARCAINE WITH EPINEPHRINE	General Injectables & Vaccines, Inc.	2021-11-17	HUMAN PRESCRIPTION DRUG LABEL	2