Application 006488

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	Yes
003	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;2%	No	No
004	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;1%	Yes	Yes
005	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML;2%	Yes	Yes
007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	Yes	Yes
008	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	Yes	Yes
010	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	Yes	Yes
012	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;0.5%	Yes	Yes
017	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1.5%	Yes	Yes
018	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1%	Yes	Yes
019	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;2%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006488-002	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-003	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982
N006488-004	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-005	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N006488-007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-008	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-010	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-012	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-017	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-018	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13
N006488-019	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N006488-002	AP
N006488-004	AP
N006488-007	AP
N006488-008	AP
N006488-010	AP
N006488-012	AP
N006488-017	AP
N006488-019	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 12 · 451 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	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 347 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	N006488-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-012	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-017	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-019	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006488-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-012	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-017	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-019	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-010	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-012	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-017	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006488-019	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-008	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-010	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-012	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-017	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006488-019	AP	1	`b8a1b40f171c…`

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	50aa6133-0776-4714-9821-fe8581f635ca	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE-MPF WITH EPI	XYLOCAINE-MPF WITH EPI	HF Acquisition Co LLC, DBA HealthFirst	c5dcb0e5-2624-9c9c-e053-2995a90a6d65	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Sportpharm LLC	74bad838-2800-4d36-a3ee-cc1d739d24c2	2026-03-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	94155012-b1fc-430a-a1f5-30c21f4a3f80	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	27c2e78d-d037-470d-b4fa-44c33d78f788	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	6899113c-dee4-4227-9f68-475fcce6b91e	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	cfcc8a07-b40c-476d-9a21-83487318ac85	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ffc87dfb-0e26-4b42-80fd-3fb7690119e3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HCL	Henry Schein, Inc.	a6019956-a6e0-4988-a870-6aee06c354c3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	REMEDYREPACK INC.	1414bcfc-1543-4ad4-83bd-4fc444a02e92	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTION	Henry Schein, Inc	9e8d0318-b2fe-4084-aedf-de97f61605a8	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	ProPharma Distribution	386c23fd-1691-98b2-e063-6294a90ab070	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	25370b0f-0ac6-4a03-abe6-d73d65192180	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAIN (LIDOCAINE HCl )	XYLOCAINE (LIDOCAINE HCL )	HF Acquisition Co LLC, DBA HealthFirst	e1838a93-7f2a-14f1-e053-2a95a90a8d69	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	4dd52202-8eef-4136-92dd-ada573b7cf74	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 63323-482 ndc (product): 63323-486 ndc (product): 63323-485
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	1986c302-82a0-95a9-e063-6294a90a3339	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	199ac3eb-1fa5-9cf5-e063-6394a90a7228	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	17e77013-f2a0-b1f7-e063-6294a90ae468	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE MPF	XYLOCAINE MPF	HF Acquisition Co LLC, DBA HealthFirst	18705416-9593-43f2-e063-6294a90a31b4	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	d5e0d06f-ba1e-44d4-aa89-39d6c146dc23	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 205 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
55154-9388	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9388	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9396	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9566	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
55154-9567	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
55154-9568	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
55154-9569	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9569	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9572	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9573	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9574	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9574	Xylocaine	LIDOCAINE HYDROCHLORIDE	Cardinal Health	NDA	Current
55154-9575	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
55154-9575	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
55154-9575	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Cardinal Health	NDA	Current
63323-481	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-481	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-481	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-481	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-481	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-482	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-483	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-483	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-483	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-483	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-483	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-484	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-484	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-484	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-484	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-484	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-485	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-486	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-487	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-487	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-487	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-487	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-487	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-488	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-488	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-488	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-488	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-488	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-489	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-489	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-489	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-489	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-489	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	NDA	Current
63323-491	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-491	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-491	Xylocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80054	SUPPL	2024-12-02
80058	SUPPL	2024-11-01
57404	SUPPL	2019-02-01
56307	SUPPL	2018-11-06
56254	SUPPL	2018-11-02
51044	SUPPL	2018-01-12
51043	SUPPL	2018-01-12
50963	SUPPL	2017-12-29
50962	SUPPL	2017-12-29
20009	SUPPL	2012-01-27
80	SUPPL	2010-03-18
10687	SUPPL	2010-02-25