Lidocaine Hydrochloride

Product NDC: 68094-081
11-digit product format: 680940081
Labeler code: 68094
Product ID: 68094-081_4711ae97-ff32-948e-e063-6394a90ae40d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Precision Dose, Inc.
Application: ANDA212821
Marketing category: ANDA
Marketing start: 2024-11-26
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
A212821-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2020-05-07
A212821-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2023-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212821-001	AP
A212821-002	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 2 · 58 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	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212821-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2020-05-07	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A212821-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212821-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212821-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212821-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212821-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212821-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212821-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212821-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212821-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212821-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212821-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212821-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212821-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212821-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212821-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212821-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212821-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212821-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212821-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212821-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212821-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212821-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212821-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212821-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212821-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212821-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212821-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212821-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212821-001	AP	1	`1c564ffb4f44…`

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
27b6ef54-a093-2bef-e063-6394a90a7912	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68094-081-01	Lidocaine Hydrochloride	5 mL in 1 VIAL	SOLUTION	5		2
68094-081-25	Lidocaine Hydrochloride	25 in 1 BOX	SOLUTION	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-081-01	ML - Milliliter	68094-081	639a56b6-21fb-4fb1-8c81-0de8b2dbc9ec	1	2025-02-10
68094-081-25	ML - Milliliter	68094-081	d0d2ac4d-e096-46d1-b77e-09ac5311e131	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-081	LIDOCAINE HYDROCHLORIDE SOLUTION [PRECISION DOSE, INC.]	1	Current NDC, 2 package rows	20241127_27b6ef54-a093-2bef-e063-6394a90a7912.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Precision Dose, Inc.	27b6ef54-a093-2bef-e063-6394a90a7912	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821 ndc (product): 68094-081
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e824ba5b-3289-5ad4-e053-2995a90acc20	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42531a38-7cff-de16-e063-6394a90a18d8	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Huons Co., Ltd.	8ec2d256-fc4f-44f6-bee2-eef2bf3bf580	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novagenix Labs LLC	7567ffb5-953a-4be9-9a02-c5a50dcd9306	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	e1eabd6b-9bb8-646f-e053-2a95a90a7b83	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212821 application number: ANDA212821

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	27b6ef54-a093-2bef-e063-6394a90a7912	2
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	27b6ef54-a093-2bef-e063-6394a90a7912	2
1737761	lidocaine HCl 100 MG per 5 ML Injection	SY	27b6ef54-a093-2bef-e063-6394a90a7912	2
1737761	lidocaine HCl 2 % per 5 ML Injection	SY	27b6ef54-a093-2bef-e063-6394a90a7912	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68094-081-01	68094008101	5 mL in 1 VIAL	5 ml				Historical
68094-081-25	68094008125	25 VIAL in 1 BOX (68094-081-25) / 5 mL in 1 VIAL (68094-081-01)	25 vial	2024-11-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride Injection USP For Infiltration and Nerve Block Rx only	Precision Dose, Inc.	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	2