Lidocaine Hydrochloride

Product NDC: 76420-078
11-digit product format: 764200078
Labeler code: 76420
Product ID: 76420-078_ead2d6e4-62f7-3b3c-e053-2a95a90a4ccd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler: Asclemed USA, Inc.
Application: ANDA084625
Marketing category: ANDA
Marketing start: 1975-06-16
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982
A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A084625-001	AP
A084625-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A084625-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084625-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084625-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084625-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084625-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084625-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084625-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084625-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084625-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084625-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084625-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084625-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084625-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084625-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084625-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084625-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084625-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084625-002	AP	1	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737761	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
fecd1797-7757-4da8-b3a1-24b258634243	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
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	Strength	SPL version
76420-078-05	Lidocaine Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-078	LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20221013_fecd1797-7757-4da8-b3a1-24b258634243.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Civica, Inc.	3c3b3888-fad3-440b-b627-6f79a2f4668f	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	995e68a7-6986-423e-e053-2995a90acd98	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	89691444-7bfb-3314-e053-2a95a90a268e	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	fecd1797-7757-4da8-b3a1-24b258634243	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 76420-078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737761	lidocaine HCl 2 % in 5 ML Injection	PSN	fecd1797-7757-4da8-b3a1-24b258634243	2
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	fecd1797-7757-4da8-b3a1-24b258634243	2
1737761	lidocaine HCl 100 MG per 5 ML Injection	SY	fecd1797-7757-4da8-b3a1-24b258634243	2
1737761	lidocaine HCl 2 % per 5 ML Injection	SY	fecd1797-7757-4da8-b3a1-24b258634243	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-078-05	76420007805	5 mL in 1 VIAL, SINGLE-DOSE (76420-078-05)	5 ml	2020-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDO CAINE HYDROCHLORIDE INJECTION, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2