Lidomark 2/5

Product NDC: 69263-852
Requested package NDC: 69263-852-01
11-digit product format: 692630852
Labeler code: 69263
Product ID: 69263-852_cd3d9628-6ce8-36e0-e053-2a95a90a1265
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lidocaine
Dosage form: KIT
Route: EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler: Oaklock, LLC
Application: ANDA084625
Marketing category: ANDA
Marketing start: 2020-07-17
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69263-852	69263-852-01	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69263-852-01	2023-10-26	C162847	48780-1	f386c649-c90f-0266-e053-dadaa90a7c1a	7cbdec55-22b2-406c-bf15-bfcf76064975
69263-852-01	2023-01-30	C162847	48780-1	f386c649-c90f-0266-e053-dadaa90a7c1a	7cbdec55-22b2-406c-bf15-bfcf76064975

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	lidocaine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69263-852-01	69263085201	1 KIT in 1 CARTON (69263-852-01) * 5 mL in 1 VIAL, SINGLE-DOSE (0143-9594-01)	1 kit	2020-07-17	0000-00-00	No	No	Current