Lidocaine Hydrochloride

Product NDC: 0404-9892
11-digit product format: 004049892
Labeler code: 0404
Product ID: 0404-9892_c440228b-f946-4025-aebe-0c94f9172dc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA083158
Marketing category: ANDA
Marketing start: 2022-01-12
Marketing end: 0000-00-00
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: 2023-12-31
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	0404-9892		D	Discontinued by firm		2026-10-15
excluded package	package	0404-9892	0404-9892-05	D	Discontinued by firm		2026-10-15

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 product	product	0404-9892		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0404-9892	0404-9892-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A083158-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	RLD, Approved before 1982
A083158-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	RLD, Approved before 1982
A083158-003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982
A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	400MG/100ML	INJECTABLE / INJECTION	Approved before 1982

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 6 · 220 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
2026-10-15 13:18:30	2026-09	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A083158-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083158-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083158-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083158-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083158-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083158-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083158-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083158-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083158-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083158-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083158-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083158-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083158-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083158-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083158-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083158-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083158-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083158-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083158-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083158-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083158-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083158-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083158-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083158-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083158-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083158-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083158-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083158-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083158-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083158-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083158-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083158-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083158-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083158-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083158-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A083158-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083158-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A083158-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083158-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083158-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9892	LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	5	Legacy NDC	20240831_08fd6cac-a539-4cc7-ab7e-c00ce20ad225.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	2177b6fe-aa37-6f6b-e063-6294a90af09a	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083158 application number: ANDA083158
2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	74450548-62f4-b77f-e053-2991aa0ae5cf	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083158 application number: ANDA083158

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9892-05	00404989205	1 CARTON in 1 BAG (0404-9892-05) > 1 SYRINGE, GLASS in 1 CARTON > 5 mL in 1 SYRINGE, GLASS	1 carton	2022-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine HCL 2% 20 mg/mL Injection, USP 5 mL PreFilled Syringe	Henry Schein, Inc.	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	5