OXYTROL

Product NDC: 0023-6153
11-digit product format: 000236153
Labeler code: 0023
Product ID: 0023-6153_12aace89-ecb2-4706-a0bd-5bd24b8db2ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Allergan, Inc.
Application: NDA021351
Marketing category: NDA
Marketing start: 2003-02-26
Substance: OXYBUTYNIN
Active strength: 3.9 mg/d
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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 42.

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
N021351-002	OXYTROL	OXYBUTYNIN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2003-02-26

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021351-002	OXYTROL	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-02-26	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021351-002	6743441	2020-04-26	U-318	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021351-002	7081249	2020-04-26	U-318	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021351-002	7081250	2020-04-26	U-318	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021351-002	7081251	2020-04-26	U-318	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021351-002	7081252	2020-04-26	U-318	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021351-002	6743441	2020-04-26	U-318	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021351-002	7081249	2020-04-26	U-318	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021351-002	7081250	2020-04-26	U-318	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021351-002	7081251	2020-04-26	U-318	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021351-002	7081252	2020-04-26	U-318	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021351-002	6743441	2020-04-26	U-318	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021351-002	7081249	2020-04-26	U-318	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021351-002	7081250	2020-04-26	U-318	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021351-002	7081251	2020-04-26	U-318	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021351-002	7081252	2020-04-26	U-318	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021351-002	6743441	2020-04-26	U-318	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021351-002	7081249	2020-04-26	U-318	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021351-002	7081250	2020-04-26	U-318	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021351-002	7081251	2020-04-26	U-318	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021351-002	7081252	2020-04-26	U-318	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021351-002	6743441	2020-04-26	U-318	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021351-002	7081249	2020-04-26	U-318	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021351-002	7081250	2020-04-26	U-318	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021351-002	7081251	2020-04-26	U-318	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021351-002	7081252	2020-04-26	U-318	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021351-002	6743441	2020-04-26	U-318	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021351-002	7081249	2020-04-26	U-318	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021351-002	7081250	2020-04-26	U-318	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021351-002	7081251	2020-04-26	U-318	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021351-002	7081252	2020-04-26	U-318	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021351-002	7179483	2020-04-26	U-318	Drug substance, Drug product	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN	3.9 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K9P6MC7092	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403799	Internal RxNorm lookup
404448	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
20dee37f-1412-44ed-9e8b-f4379ce23eb0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3544f362-07fc-93b1-457b-1fba00be087a	Product name	8	20230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4	Product name	8	20210525
982338c6-c45c-b6b4-1452-14b01fbdf98d	Product name	2	20180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6	Product name	2	20171212
3544f362-07fc-93b1-457b-1fba00be087a	Product name	2	20171212
8b00ae7e-01f2-f83c-632e-edfc23808364	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0023-6153-08	OXYTROL	1 in 1 POUCH	PATCH	1		8
0023-6153-08	OXYTROL	8 in 1 BOX	PATCH	8		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-6153-08	EA - Each	0023-6153	ddbbd75f-4a4c-4909-b3f3-71797afb879f	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-6153	OXYTROL (OXYBUTYNIN) PATCH [ALLERGAN, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250109_20dee37f-1412-44ed-9e8b-f4379ce23eb0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYTROL	OXYBUTYNIN	Allergan, Inc.	20dee37f-1412-44ed-9e8b-f4379ce23eb0	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021351 application number: NDA021351 ndc (product): 0023-6153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K9P6MC7092	OXYBUTYNIN	5633-20-5	OXYBUTYNIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403799	oxyBUTYnin 3.9 MG/Day Twice Weekly Transdermal System	PSN	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
404448	OXYTROL 3.9 MG/Day Twice Weekly Transdermal System	PSN	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
404448	84 HR oxybutynin 0.162 MG/HR Transdermal System [Oxytrol]	SBD	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
403799	84 HR oxybutynin 0.162 MG/HR Transdermal System	SCD	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
404448	84 HR Oxytrol 0.162 MG/HR Transdermal System	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
403799	oxybutynin 0.162 MG/HR 84 HR Transdermal Patch	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
403799	oxybutynin 3.9 MG/Day Twice Weekly Transdermal Patch	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
403799	oxybutynin 3.9 MG/Day Twice Weekly Transdermal System	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
404448	Oxytrol 3.9 MG/Day Twice Weekly Transdermal Patch	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8
404448	OXYTROL 3.9 MG/Day Twice Weekly Transdermal System	SY	20dee37f-1412-44ed-9e8b-f4379ce23eb0	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-6153-08	00023615308	8 POUCH in 1 BOX (0023-6153-08) / 1 PATCH in 1 POUCH / 4 d in 1 PATCH	8 pouch	2003-02-26	0000-00-00	No	No	Current