Application 083158

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	Yes
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	Yes
003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	20%	No	No
005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/100ML	No	No
006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	400MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A083158-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	RLD, Approved before 1982
A083158-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	RLD, Approved before 1982
A083158-003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982
A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	Approved before 1982
A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	LIDOCAINE HYDROCHLORIDE	400MG/100ML	INJECTABLE / INJECTION	Approved before 1982

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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-003	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-005	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%	200MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-006	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%	400MG/100ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083158-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083158-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083158-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083158-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083158-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083158-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083158-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083158-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083158-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083158-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083158-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083158-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083158-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083158-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083158-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083158-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083158-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083158-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083158-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083158-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083158-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083158-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083158-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083158-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083158-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083158-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083158-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083158-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083158-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083158-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083158-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083158-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083158-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083158-002	AP	1	`87673890dc5c…`

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	HF Acquisition Co LLC, DBA HealthFirst	2177b6fe-aa37-6f6b-e063-6294a90af09a	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083158 application number: ANDA083158
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ad1ef0a8-88db-4648-c098-d009eaeb4e5b	2026-06-09	Warnings, Adverse reactions	Exact identifier ndc (product): 0409-4904 ndc (product): 0409-4903
2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	74450548-62f4-b77f-e053-2991aa0ae5cf	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083158 application number: ANDA083158 ndc (product): 51662-1231
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	7445cb32-208b-cbf7-e053-2a91aa0ad429	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083158 application number: ANDA083158 ndc (product): 51662-1230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9890	Lidocaine Hydrochloride	Lidocaine	Henry Schein, Inc.	ANDA	Current
0404-9890	Lidocaine Hydrochloride	Lidocaine	Henry Schein, Inc.	ANDA	Current
0404-9892	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9892	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Henry Schein, Inc.	ANDA	Current
0409-4903	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4903	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4903	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4903	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4903	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4904	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4904	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4904	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4904	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4904	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1230	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1230	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1230	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1230	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1231	2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1231	2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1231	2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1231	2% LIDOCAINE HCI	2% LIDOCAINE HCI	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
52584-903	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-903	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-903	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-903	Lidocaine Hydrochloride	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-904	Lidocaine Hydrochloride	Lidocaine	General Injectables & Vaccine, Inc	ANDA	Current
52584-904	Lidocaine Hydrochloride	Lidocaine	General Injectables & Vaccine, Inc	ANDA	Current
52584-904	Lidocaine Hydrochloride	Lidocaine	General Injectables & Vaccine, Inc	ANDA	Current
55154-3190	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-3190	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-3190	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current