Application 013077

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE	LIDOCAINE	SUPPOSITORY;RECTAL	100MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N013077-001	XYLOCAINE	LIDOCAINE	100MG	SUPPOSITORY / RECTAL		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 2 · 43 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	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`f41ea6bd6efb…`

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 18 of 26 · 502 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocore	LIDOCAINE	iON Pharma, LLC	204c3e50-1ac8-f442-e063-6294a90ae7b5	2025-02-05	Warnings	Name fallback generic name: LIDOCAINE
lidocaine	LIDOCAINE	Nivagen Pharmaceuticals, Inc.	32964ec3-1880-477b-9f71-2222c39106aa	2025-01-23	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	feb8692a-9c08-0d5c-e053-6394a90a904b	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	PHARMACURE LLC	53384c51-6da1-4fa4-8782-2606ca3d1c6f	2025-01-22	Warnings	Name fallback generic name: LIDOCAINE
Care Science	LIDOCAINE	ASO LLC	2c399fec-bce7-2a41-e063-6294a90a0e73	2025-01-21	Warnings	Name fallback generic name: LIDOCAINE
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Name fallback generic name: LIDOCAINE
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief 4% Lidocaine	LIDOCAINE	Unexo Life Sciences Private Limited	bfee9be1-b265-44bd-8e82-2ec27132f82b	2025-01-13	Warnings	Name fallback generic name: LIDOCAINE
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Name fallback generic name: LIDOCAINE
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Name fallback generic name: LIDOCAINE
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18bae4a-11ac-7319-e053-2995a90ad1e8	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Name fallback generic name: LIDOCAINE
LMR Plus	LIDOCAINE	V2 Pharma, LLC	7c84e443-67fe-40b5-b721-86e9e7c4d490	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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