Application 086283

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	JELLY;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A086283-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086283-001	AT

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A086283-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A086283-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086283-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086283-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086283-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086283-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086283-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086283-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086283-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086283-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086283-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086283-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086283-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086283-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086283-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086283-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086283-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086283-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086283-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086283-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086283-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086283-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086283-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086283-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086283-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086283-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086283-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086283-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086283-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086283-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086283-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086283-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086283-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086283-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086283-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086283-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086283-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086283-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086283-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086283-001	AT	1	`3a93d1ddd44b…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f73d4546-c9ac-4155-8492-552d6ce70c84	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 0404-9900
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f0617ab8-555f-4cbe-9795-c922f5ef176e	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 0404-9898
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 0404-9899
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	0cbc37d3-c2d6-4747-9834-7c23b38fcc20	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 76329-3011 ndc (product): 76329-3012 ndc (product): 76329-3013 ndc (product): 76329-3015
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4bf5905-add7-1cb0-e053-2995a90a7334	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 51662-1551
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4c0df51-cc37-323d-e053-2995a90a154a	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 51662-1552
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	95351883-ec37-f94a-e053-2995a90aa36a	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283 ndc (product): 51662-1389

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9898	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9898	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9899	Lidocaine Hydrochloride	lidocaine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9899	Lidocaine Hydrochloride	lidocaine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9900	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9900	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
50090-4538	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4554	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1389	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1389	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1551	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1552	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-013	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-015	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-030	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-030	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-030	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-034	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-034	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-034	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-034	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-035	Lidocaine Hydrochloride	lidocaine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-035	Lidocaine Hydrochloride	lidocaine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-035	Lidocaine Hydrochloride	lidocaine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
55154-3953	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-3953	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-3955	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-3955	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
76329-3011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3012	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3012	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3013	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3013	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3015	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3015	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current