Application 010418

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
005	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
006	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1%	No	No
007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
008	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;2%	No	No
009	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	No	No
010	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N010418-005	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982
N010418-006	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982
N010418-007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982
N010418-008	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982
N010418-009	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982
N010418-010	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-009	XYLOCAINE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010418-010	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010418-005	XYLOCAINE	1%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010418-006	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010418-007	XYLOCAINE	2%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010418-008	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`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 15 of 16 · 315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86083fea-c064-4ef7-e053-2a91aa0ac17c	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86093c75-6dde-bb16-e053-2991aa0ab6ef	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	79798b21-026d-1b4c-e053-2a91aa0a0129	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	89691444-7bfb-3314-e053-2a95a90a268e	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9c9655fd-89a9-77c8-e053-2a95a90a0c99	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e412b4c-e24f-69ea-e053-2995a90ac600	2023-05-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e049bbe-0f4d-988e-e053-2a95a90a3691	2023-05-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b63614eb-8776-4cd0-e053-2995a90a8f82	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee	2023-04-27	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e8b217-a183-0d91-e053-2a95a90a4a44	2023-04-25	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	55a8372e-70d6-4b70-ac95-5226d0f5812a	2023-03-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
PharmapureRx Lidocaine HCl 4.12%	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	b7a77ad1-821b-4388-a97c-aadb1340c536	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	5d3e9984-cef9-46f2-a6c9-3be8b26f45b3	2022-12-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	B. Braun Medical Inc.	e0e479e6-4c94-44d0-8074-d0ee7b2bde22	2022-10-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	fecd1797-7757-4da8-b3a1-24b258634243	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	8ae0656c-36fb-48fb-886b-1031d11da552	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	deec52c7-ebcf-422e-beab-bc1df2fe30cb	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidotran	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	cf715e54-c413-1e8f-e053-2995a90a076d	2022-09-19	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novitium Pharma LLC	ffb2d794-2c88-48a2-beff-d01b6fcea51f	2022-03-25	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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