Application 018461

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/100ML	No	No
002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/100ML	No	No
003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	400MG/100ML	No	No
004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	800MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018461-001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	100MG/100ML	INJECTABLE / INJECTION		Approved before 1982
N018461-002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018461-003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	400MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018461-004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	800MG/100ML	INJECTABLE / INJECTION	AP		1982-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018461-002	AP
N018461-003	AP
N018461-004	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 5 of 5 · 176 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
2022-10-28 04:53 UTC	2022-10	N018461-001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	100MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018461-002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018461-003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018461-004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	AP		1982-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018461-001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	100MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018461-002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018461-003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018461-004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	AP		1982-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018461-001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	100MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018461-002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018461-003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018461-004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	AP		1982-02-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018461-001	LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER	100MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018461-002	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018461-003	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018461-004	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	AP		1982-02-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018461-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018461-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018461-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018461-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018461-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018461-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018461-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018461-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018461-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018461-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018461-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018461-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018461-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018461-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018461-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018461-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018461-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018461-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018461-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018461-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018461-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018461-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018461-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018461-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018461-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018461-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018461-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018461-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018461-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018461-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018461-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018461-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018461-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018461-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018461-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018461-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018461-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018461-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018461-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018461-002	AP	1	`79d66fd596c7…`

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 and Dextrose	LIDOCAINE HYDROCHLORIDE	Baxter Healthcare Corporation	f21512ea-c7c3-4766-b976-b2c0b5616bf0	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018461 application number: NDA018461 ndc (product): 0338-0409 ndc (product): 0338-0411
LIDOCAINE HYDROCHLORIDE AND DEXTROSE	LIDOCAINE HYDROCHLORIDE AND DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	1bf999b5-e290-dcbd-e063-6294a90a2bab	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018461 application number: NDA018461

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0409	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
0338-0411	Lidocaine Hydrochloride and Dextrose	Lidocaine Hydrochloride	Baxter Healthcare Corporation	NDA	Current
51662-1302	LIDOCAINE HCI AND DEXTROSE	LIDOCAINE HCI AND DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1302	LIDOCAINE HCI AND DEXTROSE	LIDOCAINE HCI AND DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1302	LIDOCAINE HCI AND DEXTROSE	LIDOCAINE HCI AND DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47243	SUPPL	2017-02-16
47133	SUPPL	2017-02-08
15010	SUPPL	2012-03-12
33493	SUPPL	2012-03-05
15009	SUPPL	2012-02-29
926	SUPPL	2003-12-16
40800	SUPPL	2002-09-10
15008	SUPPL	2002-01-23
11223	SUPPL	2002-01-23