Application 088325

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		1984-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088325-001	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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088325-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	INJECTABLE / INJECTION	AP	1984-07-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088325-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088325-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088325-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088325-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088325-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088325-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088325-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088325-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088325-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088325-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088325-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088325-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088325-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088325-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088325-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088325-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088325-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088325-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088325-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088325-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088325-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088325-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088325-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088325-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088325-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088325-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088325-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088325-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088325-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088325-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088325-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088325-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088325-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088325-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088325-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088325-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088325-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088325-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088325-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088325-001	AP	1	`e64feba35796…`

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 · 2 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): 088325 application number: ANDA088325 ndc (product): 0409-4275
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	952ffcce-0ec4-61c9-e053-2995a90a84af	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088325 application number: ANDA088325 ndc (product): 51662-1416

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4275	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1416	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1416	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1416	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current