Xylocaine

Product NDC: 65219-810
11-digit product format: 652190810
Labeler code: 65219
Product ID: 65219-810_db90b9bc-09cb-4f67-8cde-bd7fc1394d17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA006488
Marketing category: NDA
Marketing start: 2020-10-30
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: 10 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Xylocaine
Brand name suffix: MPF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EC2CNF7XFP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737568	Internal RxNorm lookup
1737569	Internal RxNorm lookup
1737757	Internal RxNorm lookup
1737758	Internal RxNorm lookup
1737761	Internal RxNorm lookup
1737762	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe265eb5-eaeb-4f47-82dd-238c1d53fec4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-810-01	XylocaineMPF	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		3
65219-810-02	XylocaineMPF	25 in 1 TRAY	INJECTION, SOLUTION	25		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-810-01	ML - Milliliter	65219-810	66fa3cf9-1650-4d5b-b2ae-17161abd8bf9	1	2025-05-14
65219-810-02	ML - Milliliter	65219-810	7141a975-e280-4253-8655-f5a96c5d5d49	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-810	XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240328_fe265eb5-eaeb-4f47-82dd-238c1d53fec4.zip

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737568	lidocaine HCl 1 % in 2 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737757	lidocaine HCl 2 % in 2 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737761	lidocaine HCl 2 % in 5 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737569	Xylocaine 1 % in 2 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737758	Xylocaine 2 % in 2 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737762	Xylocaine 2 % in 5 ML Injection	PSN	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737569	2 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]	SBD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737758	2 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]	SBD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737762	5 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]	SBD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737568	2 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737757	2 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737569	2 ML Xylocaine 10 MG/ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737758	2 ML Xylocaine 20 MG/ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737762	5 ML Xylocaine 20 MG/ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737568	lidocaine HCl 1 % per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737761	lidocaine HCl 100 MG per 5 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737757	lidocaine HCl 2 % per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737761	lidocaine HCl 2 % per 5 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737568	lidocaine HCl 20 MG per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737757	lidocaine HCl 40 MG per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737569	Xylocaine-MPF 1 % per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737762	Xylocaine-MPF 100 MG per 5 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737758	Xylocaine-MPF 2 % per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737762	Xylocaine-MPF 2 % per 5 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737569	Xylocaine-MPF 20 MG per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3
1737758	Xylocaine-MPF 40 MG per 2 ML Injection	SY	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-810-01	65219081001	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
65219-810-02	65219081002	25 VIAL, SINGLE-DOSE in 1 TRAY (65219-810-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-810-01)		2020-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)	Fresenius Kabi USA, LLC	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	3