Application 083173

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083173-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
A083173-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	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
A083173-001	AP
A083173-002	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 1 of 3 · 82 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	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083173-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083173-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A083173-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083173-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083173-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083173-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083173-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083173-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083173-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083173-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083173-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083173-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083173-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083173-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083173-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083173-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083173-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083173-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083173-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083173-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083173-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083173-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083173-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083173-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083173-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083173-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083173-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083173-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083173-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083173-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083173-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083173-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083173-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083173-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083173-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083173-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083173-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083173-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083173-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083173-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083173-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083173-002	AP	1	`782e0a99824c…`

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	REMEDYREPACK INC.	f824b48c-7039-4ce1-b3df-b3597aba5beb	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083173 application number: ANDA083173
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	96117178-ebf0-1335-e053-2a95a90ac105	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083173 application number: ANDA083173 ndc (product): 51662-1382
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6947af02-f4e0-7f9c-e053-2a91aa0a45cd	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083173 application number: ANDA083173 ndc (product): 71872-7126
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	5d3e9984-cef9-46f2-a6c9-3be8b26f45b3	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083173 application number: ANDA083173 ndc (product): 76329-3390

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1382	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1382	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1382	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
71872-7126	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7126	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-3390	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current