Lidocaine Hydrochloride and Epinephrine

Product NDC: 0404-9788
11-digit product format: 004049788
Labeler code: 0404
Product ID: 0404-9788_96589b9d-b9c8-49f5-a5a4-5abdf8d00dd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Henry Schein, Inc.
Application: ANDA089646
Marketing category: ANDA
Marketing start: 2025-02-17
Substance: EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength: 10; 20 ug/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089646-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089646-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089646-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089646-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089646-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089646-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089646-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089646-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089646-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089646-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089646-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089646-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089646-001	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A089646-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089646-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089646-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089646-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089646-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089646-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine Hydrochloride and Epinephrine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	10 ug/mL
EPINEPHRINE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
YKH834O4BH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010759	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
5692e28d-559c-4b6a-8421-fa85d7155818	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
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
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9788-20	Lidocaine Hydrochloride and Epinephrine	1 in 1 BAG	INJECTION, SOLUTION	1		2
0404-9788-20	Lidocaine Hydrochloride and Epinephrine	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9788	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	2	Current NDC, 2 package rows	20250223_5692e28d-559c-4b6a-8421-fa85d7155818.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
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	2f94f711-14c4-48ec-c5a3-c5ec4b8e8729	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCL AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a09613b2-4337-5b52-e053-2995a90ab74b	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	ProPharma Distribution	43048b6b-3c83-eef4-e063-6294a90a34cb	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	5692e28d-559c-4b6a-8421-fa85d7155818	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646 ndc (product): 0404-9788
LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCL AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a098ab6c-143f-77a5-e053-2a95a90a3e0a	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YKH834O4BH	EPINEPHRINE	51-43-4	EPINEPHRINE
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010759	lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	5692e28d-559c-4b6a-8421-fa85d7155818	2
1010759	epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable Solution	SCD	5692e28d-559c-4b6a-8421-fa85d7155818	2
1010759	epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable Solution	SY	5692e28d-559c-4b6a-8421-fa85d7155818	2
1010759	epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable Solution	SY	5692e28d-559c-4b6a-8421-fa85d7155818	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0404-9788-20	00404978820	1 VIAL, MULTI-DOSE in 1 BAG (0404-9788-20) / 20 mL in 1 VIAL, MULTI-DOSE	2025-02-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride and Epinephrine Injection, USP	Henry Schein, Inc.	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	2