Lidocaine Hydrochloride and Epinephrine

Product NDC: 0404-9891
11-digit product format: 004049891
Labeler code: 0404
Product ID: 0404-9891_e7e3772b-2b6d-4103-8ccf-f62a909ec353
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride and Epinephrine
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION
Labeler: Henry Schein, Inc.
Application: ANDA089644
Marketing category: ANDA
Marketing start: 2022-01-12
Substance: EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength: 10; 10 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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0404-9891	0404-9891-30	D	Discontinued by firm		2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0404-9891	0404-9891-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0404-9891	0404-9891-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP		1988-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089644-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089644-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	1988-06-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089644-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089644-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089644-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089644-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089644-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089644-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089644-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089644-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089644-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089644-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089644-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089644-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089644-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089644-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089644-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089644-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089644-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089644-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089644-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089644-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089644-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089644-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089644-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089644-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089644-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089644-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089644-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089644-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089644-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089644-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089644-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089644-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089644-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089644-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089644-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089644-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089644-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089644-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089644-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089644-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine Hydrochloride and Epinephrine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	10 ug/mL
EPINEPHRINE	10 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
1010751	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
c3490a23-14c4-43f7-b066-96a4c4298fde	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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0404-9891-20	Lidocaine Hydrochloride and Epinephrine	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	10
0404-9891-20	Lidocaine Hydrochloride and Epinephrine	1 in 1 BAG	INJECTION, SOLUTION	1	10
0404-9891-30	Lidocaine Hydrochloride and Epinephrine	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	10
0404-9891-30	Lidocaine Hydrochloride and Epinephrine	1 in 1 BAG	INJECTION, SOLUTION	1	10
0404-9891-50	Lidocaine Hydrochloride and Epinephrine	1 in 1 BAG	INJECTION, SOLUTION	1	10
0404-9891-50	Lidocaine Hydrochloride and Epinephrine	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9891	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	7	Current NDC, Legacy NDC, 6 package rows	20250309_c3490a23-14c4-43f7-b066-96a4c4298fde.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	76176d50-a987-c9f9-e053-2991aa0aea0f	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644
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): 089644 application number: ANDA089644
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	27194739-3382-46b0-94cd-096531345325	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Cardinal Health 107, LLC	77fd6ee4-108f-4525-8df5-7db9236042ee	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Sportpharm LLC	2c58deba-dbb2-4e73-a173-36053536f03e	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	c3490a23-14c4-43f7-b066-96a4c4298fde	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644 ndc (product): 0404-9891
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	95309440-34ec-11fe-e053-2a95a90a1c90	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644
LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	957506a5-1b09-0736-e053-2995a90a0b63	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089644 application number: ANDA089644

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
1010751	lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution	PSN	c3490a23-14c4-43f7-b066-96a4c4298fde	10
1010751	epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution	SCD	c3490a23-14c4-43f7-b066-96a4c4298fde	10
1010751	epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable Solution	SY	c3490a23-14c4-43f7-b066-96a4c4298fde	10
1010751	lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution	SY	c3490a23-14c4-43f7-b066-96a4c4298fde	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9891-20	00404989120	1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSE	2022-01-12	0000-00-00	No	No	Current
0404-9891-30	00404989130	1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-30) > 20 mL in 1 VIAL, MULTI-DOSE	2022-01-12	0000-00-00	No	No	Current
0404-9891-50	00404989150	1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50) / 50 mL in 1 VIAL, MULTI-DOSE	2022-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride and Epinephrine	Henry Schein, Inc.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	10