Nicotine Transdermal System

Product NDC: 0363-1241
Requested package NDC: 0363-1241-01
11-digit product format: 003631241
Labeler code: 0363
Product ID: 0363-1241_28902497-00d5-7357-724b-7f3e630a1025
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Transdermal System
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Walgreens
Application: ANDA074612
Marketing category: ANDA
Marketing start: 2017-09-22
Marketing end: 2023-03-31
Substance: NICOTINE
Active strength: 14 mg/24h
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-1241	0363-1241-01	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A074612-001	NICOTINE	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20
A074612-002	NICOTINE	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28
A074612-003	NICOTINE	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`8072bd15b7f6…`

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Ingenus Pharmaceuticals, LLC	0c25e8b8-7202-459b-85ac-0d757f344b34	2026-05-20	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	AmerisourceBergen Drug Corporation	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	2026-03-31	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Quitine LLC	e4761ed6-509b-4e43-88e0-b0229d24859a	2026-03-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	H-E-B	da35e19d-b0aa-8a5f-140e-7601bd2027fe	2026-03-06	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Topco Associates LLC	a631d31d-38e6-1772-8b6d-57672b785d98	2026-03-06	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Meijer, Inc.	78b85047-b412-44fa-91e1-a1c891d47876	2026-01-22	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Aveva Drug Delivery Systems, Inc.	55442645-fa9b-4a9b-81e2-345ad062a124	2025-11-18	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Medline	NICOTINE	Medline Industries, LP	e11a4b7e-6f1f-24db-e053-2a95a90a0d09	2025-11-04	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Aveva Drug Delivery Systems Inc.	7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe	2025-07-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Strategic Sourcing Services LLC	a08022ff-e412-47f9-8132-318f55528c5c	2025-07-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE	EXELAN PHARMACEUTICALS, INC.	5aeb4f5c-7cc4-4532-b76e-53bdee8e7220	2025-06-01	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	A-S Medication Solutions	13aa171e-7425-47fc-b618-7759840f0618	2025-05-30	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Walgreens	5aadb95f-428c-b637-01f4-50d5866ced0c	2025-03-25	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	BluePoint Laboratories	a8a769ce-e41a-696f-e053-2a95a90a6b18	2025-03-25	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine Transdermal System	NICOTINE TRANSDERMAL SYSTEM	Cardinal Health	c4cc8321-807f-258f-71f5-e993f633f9e3	2024-11-18	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
foster and thrive STEP 3	NICOTINE TRANSDERMAL SYSTEM	Strategic Sourcing Services LLC	d992645a-f185-48be-887a-e89ab5fcf039	2024-06-11	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612
Nicotine	NICOTINE	Rugby Laboratories	2dd4cbda-5c46-4655-b69d-21b7d2e912cf	2024-06-05	Warnings	Exact identifier application applno (ANDA): 074612 application number: ANDA074612

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1241-01	00363124101	14 POUCH in 1 CARTON (0363-1241-01) > 1 h in 1 POUCH	14 pouch	2017-09-22	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Transdermal System - nicotine patch, extended release	Walgreens \| Aveva Drug Delivery Systems	2020-10-23	HUMAN OTC DRUG LABEL	5