Application 089646

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;2%	No	Yes

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
A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21

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	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RS	1988-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089646-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	AP	RS	1988-06-21	`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	A089646-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089646-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089646-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089646-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089646-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089646-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089646-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089646-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089646-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089646-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089646-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089646-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089646-001	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A089646-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089646-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089646-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089646-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089646-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089646-001	AP	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	2f94f711-14c4-48ec-c5a3-c5ec4b8e8729	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646 ndc (product): 0409-3182
LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCL AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a09613b2-4337-5b52-e053-2995a90ab74b	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646 ndc (product): 51662-1503
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	ProPharma Distribution	43048b6b-3c83-eef4-e063-6294a90a34cb	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646 ndc (product): 0404-9896
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	5692e28d-559c-4b6a-8421-fa85d7155818	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646
LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCL AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a098ab6c-143f-77a5-e053-2a95a90a3e0a	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089646 application number: ANDA089646 ndc (product): 51662-1504

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9896	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	Henry Schein, Inc.	ANDA	Current
0404-9896	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	Henry Schein, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE and EPINEPHRINE	Hospira, Inc.	ANDA	Current
51662-1503	LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCl AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1503	LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCl AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1504	LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCl AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1504	LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCl AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1504	LIDOCAINE HCl AND EPINEPHRINE	LIDOCAINE HCl AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
52584-182	Lidocaine Hydrochloride and Epinephrine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines	ANDA	Current
55154-3182	Lidocaine Hydrochloride and Epinephrine	lidocaine hydrochloride anhydrous and epinephrine	Cardinal Health	ANDA	Current
61699-3182	Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE	US MedSource, LLC	ANDA	Current
63739-475	Lidocaine Hydrochloride and Epinephrine	lidocaine hydrochloride anhydrous and epinephrine	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current