Lidocaine Hydrochloride

Product NDC: 71872-7301
Requested package NDC: 71872-7301-1
11-digit product format: 718727301
Labeler code: 71872
Product ID: 71872-7301_fa19aa30-e94d-6f5d-e053-6294a90aaff0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA083158
Marketing category: ANDA
Marketing start: 2005-12-01
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

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	71872-7301	71872-7301-1	E	Excluded after deficient or non-compliant submission was not corrected		2026-08-03

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

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 · 205 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`

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
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
71872-7301-1	Lidocaine Hydrochloride	1 in 1 BAG	INJECTION, SOLUTION	1		8
71872-7301-1	Lidocaine Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71872-7301	LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]	8	Current NDC, 2 package rows	20230425_f98b8ed2-5faa-d998-e053-6394a90ac71d.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 · 3 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
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	7445cb32-208b-cbf7-e053-2a91aa0ad429	2024-01-29	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
1012068	lidocaine HCl 2 % in 5 ML Prefilled Syringe	PSN	f98b8ed2-5faa-d998-e053-6394a90ac71d	8
1012068	5 ML lidocaine hydrochloride 20 MG/ML Prefilled Syringe	SCD	f98b8ed2-5faa-d998-e053-6394a90ac71d	8
1012068	lidocaine HCl 100 MG per 5 ML Prefilled Syringe	SY	f98b8ed2-5faa-d998-e053-6394a90ac71d	8
1012068	lidocaine HCl 2 % per 5 ML Prefilled Syringe	SY	f98b8ed2-5faa-d998-e053-6394a90ac71d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71872-7301-1	71872730101	1 CARTON in 1 BAG (71872-7301-1) / 1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE	1 carton	2023-02-14	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE HYDROCHLORIDE INJECTION, USP	Medical Purchasing Solutions, LLC	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	8