Application 040014

Type: ANDA
Sponsor: HI TECH PHARMA

Application Products#

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

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
A040014-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10

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	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040014-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	AT	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	AT	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a41d694-4628-4911-e053-2991aa0a91e5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040014 application number: ANDA040014 ndc (product): 66267-962

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-0775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
21695-783	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Rebel Distributors Corp	ANDA	Current
24451-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	LLC Federal Solutions	ANDA	Current
49999-140	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Akorn	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Akorn	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Akorn	ANDA	Current
50383-775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Akorn	ANDA	Current
50436-0775	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Unit Dose Services	ANDA	Current
51021-440	Professional Medicated DNA Collection	Lidocaine Hydrochloride and Glycerin	Sircle Laboratories, LLC	ANDA	Current
53002-3430	Lidocaine Hydrochloride	Lidocaine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-9626	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-9626	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-9626	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
61919-520	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-520	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
66267-962	Lidocaine Hydrochloride	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-962	Lidocaine Hydrochloride	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9799	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9799	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9799	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9799	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9799	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69938-151	Medicated DNA Collection Kit	lidocaine hydrochloride, glycerin	TrueFit RX LLC	ANDA	Current
70518-1894	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1894	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1894	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70529-441	DX1 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-441	DX1 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-441	DX1 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-442	DX2 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-442	DX2 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70529-442	DX2 OraGenomic Medicated DNA Collection Screen	Lidocaine Hydrochloride	IT3 Medical LLC	ANDA	Current
70859-043	Medicated Buccal DNA Collection Kit	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-043	Medicated Buccal DNA Collection Kit	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-044	Medicated Buccal DNA Collection Kit 2	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-044	Medicated Buccal DNA Collection Kit 2	Lidocaine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current