Application 080408

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080408-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982
A080408-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1.5%	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
A080408-001	AP
A080408-002	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 3 of 3 · 86 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
2022-09-29 23:25 UTC	2022-09	A080408-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080408-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1.5%	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080408-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080408-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1.5%	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080408-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080408-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1.5%	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080408-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080408-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080408-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080408-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080408-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080408-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080408-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080408-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080408-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080408-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080408-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080408-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080408-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080408-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080408-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080408-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080408-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080408-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080408-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080408-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080408-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080408-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080408-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080408-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080408-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080408-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080408-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080408-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080408-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080408-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080408-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080408-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080408-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080408-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080408-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080408-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080408-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080408-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080408-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080408-002	AP	1	`74a2ff9319b5…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	3b2dd84e-cee8-4e58-d494-395a65a353a0	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (product): 0409-4713 ndc (product): 0409-4776
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Henry Schein, Inc.	a5d4b206-cc53-470f-9bca-abfc6ea5cc99	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (product): 0404-9887
LIDOCAINE HCl	LIDOCAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e39435a3-1f69-78c5-e053-2995a90a7fc3	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (product): 51662-1593
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	deec52c7-ebcf-422e-beab-bc1df2fe30cb	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (product): 76420-084

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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9887	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	Henry Schein, Inc.	ANDA	Current
0404-9887	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	Henry Schein, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4713	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4776	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1593	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-713	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	General Injectables & Vaccines, Inc	ANDA	Current
52584-713	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	General Injectables & Vaccines, Inc	ANDA	Current
52584-713	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	General Injectables & Vaccines, Inc	ANDA	Current
52584-713	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	General Injectables & Vaccines, Inc	ANDA	Current
52584-713	Lidocaine Hydrochloride	Lidocaine Hydrochloride Anhydrous	General Injectables & Vaccines, Inc	ANDA	Current
53225-3800	ReadySharp Lidocaine	LIDOCAINE HYDROCHLORIDE	Terrain Pharmaceuticals	ANDA	Current
53225-3800	ReadySharp Lidocaine	LIDOCAINE HYDROCHLORIDE	Terrain Pharmaceuticals	ANDA	Current
53225-3800	ReadySharp Lidocaine	LIDOCAINE HYDROCHLORIDE	Terrain Pharmaceuticals	ANDA	Current
53225-3800	ReadySharp Lidocaine	LIDOCAINE HYDROCHLORIDE	Terrain Pharmaceuticals	ANDA	Current
55154-3187	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Cardinal Health	ANDA	Current
55154-3187	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Cardinal Health	ANDA	Current
76420-084	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-084	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current