Application 020612

Type: NDA
Sponsor: TEIKOKU PHARMA USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDODERM	LIDOCAINE	PATCH;TOPICAL	5%	Yes	Yes

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
N020612-001	LIDODERM	LIDOCAINE	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020612-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`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	N020612-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020612-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020612-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020612-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020612-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020612-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020612-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020612-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020612-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020612-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020612-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020612-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020612-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020612-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020612-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020612-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020612-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020612-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020612-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020612-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020612-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020612-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020612-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020612-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020612-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020612-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020612-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020612-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020612-001	AB	1	`cb3db0bc1861…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	St. Mary's Medical Park Pharmacy	9dc3059c-3a3d-5810-e053-2a95a90ab0ba	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 60760-880
Lidocaine	LIDOCAINE	Golden State Medical Supply, Inc.	0bef12dd-6cea-d12b-e063-6394a90a002e	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Par Health USA, LLC	2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 0603-1880
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	323e0ec2-c2e5-47d1-a39f-69ff5c99e324	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 68788-7159
LIDOCAINE	LIDOCAINE	DIRECT RX	a575bcb8-478f-1f7e-e053-2995a90a4b12	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 61919-588
Lidocaine	LIDOCAINE	Sportpharm LLC	4611f0da-a41d-4861-9dd6-f16f1b007d33	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	PHOENIX RX LLC	3c69e03c-e176-2c23-e063-6394a90aa41f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	0748b9e3-1247-4eeb-8158-3d641b2ad85d	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	A-S Medication Solutions	e23a92e6-3445-4ba7-9ad2-86a3eec1717e	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 50090-1359
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	fa69dfdf-ab73-48a9-944d-25e88d7766df	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 55154-7228
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	94ab1b99-e203-4a14-b852-42d3b37999c3	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	f7ada189-7463-4bc7-83e7-f140558ecacf	2024-12-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Quality Care Products LLC	f20ab860-e49a-4f3f-868e-6a60780af5a7	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 55700-142
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	1b561cc6-1d36-e259-e063-6294a90aacbd	2024-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	65cf652c-87f2-43c6-a6f8-e4a83b42ce78	2024-01-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 71335-1934
LIDODERM	LIDOCAINE PATCH 5%	TPU Pharma, Inc.	db0092f5-02a0-4076-ac32-969f075a6ab1	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 61959-001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-1880	Lidocaine	lidocaine	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
49999-419	LIDODERM	lidocaine	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-1359	Lidocaine	lidocaine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-1331	LIDODERM	lidocaine	Unit Dose Services	NDA	Current
55154-7228	Lidocaine	lidocaine	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-7228	Lidocaine	lidocaine	Cardinal Health	NDA AUTHORIZED GENERIC	Current
55154-7228	Lidocaine	lidocaine	Cardinal Health 107, LLC	NDA AUTHORIZED GENERIC	Current
55700-142	Lidocaine	lidocaine	Lake Erie Medical DBA Qua	NDA AUTHORIZED	Current
55700-142	Lidocaine	lidocaine	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
60760-880	Lidocaine	lidocaine	St. Mary's Medical Park Pharmacy	NDA AUTHORIZED GENERIC	Current
61919-588	LIDOCAINE	LIDOCAINE	DIRECT RX	NDA AUTHORIZED GENERIC	Current
61959-001	LIDODERM	Lidocaine Patch 5%	TPU Pharma, Inc.	NDA	Current
63481-687	LIDODERM	lidocaine	Endo Pharmaceuticals, Inc.	NDA	Current
63481-687	LIDODERM	lidocaine	Endo Pharmaceuticals Inc.	NDA	Current
63481-687	LIDODERM	lidocaine	Endo Pharmaceuticals, Inc.	NDA	Current
68071-2460	Lidocaine	lidocaine	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68788-7159	Lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7159	Lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7159	Lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7159	Lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
71335-1934	Lidocaine	lidocaine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
76519-1044	LIDOCAINE	LIDOCAINE	H.J. Harkins Company, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56357	SUPPL	2018-11-08
56265	SUPPL	2018-11-05
12848	SUPPL	2015-01-08
2879	SUPPL	2015-01-08
34958	SUPPL	2010-04-19
2878	SUPPL	2010-04-19
41480	SUPPL	2006-10-26
20767	SUPPL	2006-10-26
12847	SUPPL	2006-05-01
2877	SUPPL	2006-05-01
34957	SUPPL	2005-05-17
2876	SUPPL	2005-05-17
20766	ORIG	1999-06-17
34956	ORIG	1999-03-19
2875	ORIG	1999-03-19