LIDOCAINE HCI

Product NDC: 51662-1230
11-digit product format: 516621230
Labeler code: 51662
Product ID: 51662-1230_101f51a1-3d8b-a803-e063-6294a90acb81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HCI
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co. LLC, DBA Health First
Application: ANDA083158
Marketing category: ANDA
Marketing start: 2018-08-25
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 10 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51662-1230		D	Discontinued by firm	2026-09-14
excluded package	package	51662-1230	51662-1230-1	D	Discontinued by firm	2026-09-14
excluded package	package	51662-1230	51662-1230-3	D	Discontinued by firm	2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 215 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
2026-09-14 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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083158-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083158-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083158-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083158-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083158-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083158-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083158-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083158-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083158-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083158-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083158-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083158-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083158-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083158-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083158-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083158-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083158-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083158-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083158-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083158-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083158-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083158-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083158-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083158-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083158-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083158-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083158-002	AP	1	`87673890dc5c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51662-1230-1	2020-02-07	C162847	48780-1	9d75b9d0-3688-f424-e053-dadaa90a57ce	LIDOCAINE HCI INJECTION, USP 1% 50mg/5mL SYR
51662-1230-1	2020-01-31	C162847	48780-1	9d75b9d0-3688-f424-e053-dadaa90a57ce	LIDOCAINE HCI INJECTION, USP 1% 50mg/5mL SYR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1230-1	LIDOCAINE HCI	1 in 1 CARTON	INJECTION, SOLUTION	1	5
51662-1230-1	LIDOCAINE HCI	5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	5	5
51662-1230-2	LIDOCAINE HCI	5 mL in 1 SYRINGE	INJECTION, SOLUTION	5	5
51662-1230-2	LIDOCAINE HCI	1 in 1 POUCH	INJECTION, SOLUTION	1	5
51662-1230-3	LIDOCAINE HCI	10 in 1 CASE	INJECTION, SOLUTION	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1230	LIDOCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]	5	Current NDC, Legacy NDC, 5 package rows	20240131_7445cb32-208b-cbf7-e053-2a91aa0ad429.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012066	lidocaine HCl 1 % in 5 ML Prefilled Syringe	PSN	7445cb32-208b-cbf7-e053-2a91aa0ad429	5
1012066	5 ML lidocaine hydrochloride 10 MG/ML Prefilled Syringe	SCD	7445cb32-208b-cbf7-e053-2a91aa0ad429	5
1012066	lidocaine HCl 1 % per 5 ML Prefilled Syringe	SY	7445cb32-208b-cbf7-e053-2a91aa0ad429	5
1012066	lidocaine HCl 50 MG per 5 ML Prefilled Syringe	SY	7445cb32-208b-cbf7-e053-2a91aa0ad429	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1230-1	51662123001	1 SYRINGE, PLASTIC in 1 CARTON (51662-1230-1) / 5 mL in 1 SYRINGE, PLASTIC		2018-08-25	0000-00-00	No	No	Current
51662-1230-2	51662123002	5 mL in 1 SYRINGE	5 ml					Historical
51662-1230-3	51662123003	10 POUCH in 1 CASE (51662-1230-3) / 1 SYRINGE in 1 POUCH (51662-1230-2) / 5 mL in 1 SYRINGE	10 pouch	2022-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE HCI INJECTION, USP 1% 50mg/5mL SYR	HF Acquisition Co. LLC, DBA Health First	2024-01-29	HUMAN PRESCRIPTION DRUG LABEL	5