Lidocaine

Product NDC: 50436-3525
Requested package NDC: 50436-3525-1
11-digit product format: 504363525
Labeler code: 50436
Product ID: 50436-3525_c10ad84b-c754-450f-ae4b-0a3fb6425e44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Unit Dose Services
Application: ANDA200675
Marketing category: ANDA
Marketing start: 2013-09-15
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 50 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-3525	50436-3525-1	I	Inactivated by FDA		2026-08-11

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200675-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2012-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200675-001	AB

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 · 41 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	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A200675-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	AB	1	`cb3db0bc1861…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-3525-1	2024-01-30	C162847	48780-1	1030e365-060e-111a-e063-dadaa90a10e2	Lidocaine Patch A200675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-3525-1	Lidocaine	30 g in 1 CARTON	PATCH	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3525-1	EA - Each	50436-3525	d58a9d80-46ab-4d48-85a4-5289306fbce6	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3525	LIDOCAINE PATCH [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20220128_103f88dc-d705-4993-bcab-e2fc12ff6024.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tridacaine II	LIDOCAINE	Trifluent Pharma LLC	1e940ba6-3916-4fc4-8886-481fc9685fc1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	PureTek Corporation	85e72943-6989-42f4-b519-a3ebbf4bc777	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	eb808fdf-0420-45e9-ad17-8380d49d5c21	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	c18799cd-9e11-4196-9ab1-0a2a84585e56	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e856dd5-f2fa-4acb-a205-f87baf26b8cc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	1d28d687-695e-4cd9-97e2-7d4fdab9772a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6d7fdc43-e493-449e-9af6-825e584b547a	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	80dadfb5-cbe6-475f-9980-a1b255982753	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	4d04052c-3e0a-469a-9265-99604f13e507	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	AVKARE	ec6a4720-9821-c0fc-e053-2995a90a05df	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745091	lidocaine 5 % Medicated Patch	PSN	103f88dc-d705-4993-bcab-e2fc12ff6024	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	103f88dc-d705-4993-bcab-e2fc12ff6024	2
1745091	lidocaine 5 % Medicated Patch	SY	103f88dc-d705-4993-bcab-e2fc12ff6024	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-3525-1	50436352501	30 g in 1 CARTON (50436-3525-1)	30 g	2022-01-01	0000-00-00	No	No	Current