MARCAINE WITH EPINEPHRINE

Product NDC: 0404-9908
11-digit product format: 004049908
Labeler code: 0404
Product ID: 0404-9908_2950b33e-2ee2-4f43-9c08-3c5edef9caae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupivacaine hydrochloride and epinephrine bitartrate
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: Henry Schein, Inc.
Application: NDA016964
Marketing category: NDA
Marketing start: 2022-01-13
Substance: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 2.5; .0091 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 420 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
2026-08-18 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…`
2025-08-23 18:47 UTC	2025-08	N016964-001	MARCAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-004	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-005	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-006	MARCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-007	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-008	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-009	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.75%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-010	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-012	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	0.25%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-013	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-08-23 18:47 UTC	2025-08	N016964-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-009	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-012	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016964-013	AP	1	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: MARCAINE WITH EPINEPHRINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 mg/mL
EPINEPHRINE BITARTRATE	.0091 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7TQO7W3VT8	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1867596	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d0d51133-882c-4f9e-ba1c-f037226305a1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9908-30	MARCAINE WITH EPINEPHRINE	1 in 1 BAG	INJECTION, SOLUTION	1		7
0404-9908-30	MARCAINE WITH EPINEPHRINE	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9908	MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240323_d0d51133-882c-4f9e-ba1c-f037226305a1.zip

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 ndc (product): 0404-9908
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1867596	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	d0d51133-882c-4f9e-ba1c-f037226305a1	7
1867596	30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	d0d51133-882c-4f9e-ba1c-f037226305a1	7
1867596	bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML Injection	SY	d0d51133-882c-4f9e-ba1c-f037226305a1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9908-30	00404990830	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30) / 30 mL in 1 VIAL, SINGLE-DOSE	2022-01-13	0000-00-00	No	No	Current