Xylocaine

Product NDC: 0404-9972
11-digit product format: 004049972
Labeler code: 0404
Product ID: 0404-9972_99c2dcbe-4d2f-4789-b672-8802bd11efcb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride and epinephrine
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: Henry Schein, Inc.
Application: NDA006488
Marketing category: NDA
Marketing start: 2022-01-10
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength: 20; .005 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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 43.

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 · 473 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
2026-09-14 22:38:34	2026-08	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 363 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N006488-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-010	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-012	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-017	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-019	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N006488-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-012	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-017	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-019	AP	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg/mL
EPINEPHRINE BITARTRATE	.005 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EC2CNF7XFP	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010688	Internal RxNorm lookup
1010692	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
cfcc8a07-b40c-476d-9a21-83487318ac85	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
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
0404-9972-20	Xylocaine	1 in 1 BAG	INJECTION, SOLUTION	1		6
0404-9972-20	Xylocaine	20 mL in 1 VIAL	INJECTION, SOLUTION	20		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9972	XYLOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240516_cfcc8a07-b40c-476d-9a21-83487318ac85.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 2 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	Fresenius Kabi USA, LLC	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a0997348-6274-060a-e053-2a95a90abea7	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a09af094-7cfc-1d47-e053-2a95a90a6b69	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	e3b3b462-8f35-68b8-e053-2995a90a6403	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE- MPF (LIDOCAINE HCl )	LIDOCAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e8b987c8-b5cb-74cd-e053-2a95a90a5a93	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	971439ed-4507-7a30-e053-2a95a90a1f1c	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	94e9f2db-af29-032e-e053-2995a90a7f7b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	0c6c5678-e987-b822-e063-6394a90ac88b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	A-S Medication Solutions	38610ee9-4e70-4a8a-a5c5-6c148cf145f0	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	ba082c2f-64f4-419d-9c88-74f203316e17	2021-08-25	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
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010688	lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML Injection	PSN	cfcc8a07-b40c-476d-9a21-83487318ac85	6
1010692	Xylocaine 2 % / EPINEPHrine 1:200,000 in 20 ML Injection	PSN	cfcc8a07-b40c-476d-9a21-83487318ac85	6
1010692	20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]	SBD	cfcc8a07-b40c-476d-9a21-83487318ac85	6
1010688	20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection	SCD	cfcc8a07-b40c-476d-9a21-83487318ac85	6
1010688	lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML Injection	SY	cfcc8a07-b40c-476d-9a21-83487318ac85	6
1010692	Xylocaine 2 % / EPINEPHrine 1:200,000 per 20 ML Injection	SY	cfcc8a07-b40c-476d-9a21-83487318ac85	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9972-20	00404997220	1 VIAL in 1 BAG (0404-9972-20) / 20 mL in 1 VIAL	1 vial	2022-01-10	0000-00-00	No	No	Current