Nicotine Transdermal System

Product NDC: 46122-353
11-digit product format: 461220353
Labeler code: 46122
Product ID: 46122-353_4e523133-7733-a6e4-e063-6394a90a2e59
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Transdermal System
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: AmerisourceBergen Drug Corporation
Application: ANDA074612
Marketing category: ANDA
Marketing start: 2024-06-25
Substance: NICOTINE
Active strength: 21 mg/24h
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Transdermal System
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	21 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198029	Internal RxNorm lookup
198030	Internal RxNorm lookup
198031	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
8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-353-74	Nicotine Transdermal System	1 h in 1 POUCH	PATCH, EXTENDED RELEASE	1		8
46122-353-74	Nicotine Transdermal System	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-353-74	EA - Each	46122-353	7211bcaf-9059-4bd0-96a5-24832253d2de	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-353	NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [AMERISOURCEBERGEN DRUG CORPORATION]	7	Current NDC, Legacy NDC, 2 package rows	20240625_8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e.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 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 ndc (product): 46122-353
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198029	nicotine 14 MG/Day 24HR Transdermal System	PSN	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198030	nicotine 21 MG/Day 24HR Transdermal System	PSN	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198031	nicotine 7 MG/Day 24HR Transdermal System	PSN	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198031	24 HR nicotine 0.292 MG/HR Transdermal System	SCD	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198029	24 HR nicotine 0.583 MG/HR Transdermal System	SCD	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198030	24 HR nicotine 0.875 MG/HR Transdermal System	SCD	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198031	nicotine 0.292 MG/HR 24HR Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198029	nicotine 0.583 MG/HR 24HR Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198030	nicotine 0.875 MG/HR 24HR Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198029	nicotine 14 MG per 24HR 1 Day Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198029	nicotine 14 MG/Day 24HR Transdermal System	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198030	nicotine 21 MG per 24HR 1 Day Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198030	nicotine 21 MG/Day 24HR Transdermal System	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198031	nicotine 7 MG per 24HR 1 Day Transdermal Patch	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8
198031	nicotine 7 MG/Day 24HR Transdermal System	SY	8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-353-74	46122035374	14 POUCH in 1 CARTON (46122-353-74) / 1 h in 1 POUCH	14 pouch	2024-06-25	0000-00-00	No	No	Current