Oxybutynin Chloride

Product NDC: 53808-1122
Requested package NDC: 53808-1122-1
11-digit product format: 538081122
Labeler code: 53808
Product ID: 53808-1122_71b66fc9-7e62-40a5-ada5-8fc45165bfac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: ANDA209335
Marketing category: ANDA
Marketing start: 2018-07-10
Marketing end: 0000-00-00
Substance: OXYBUTYNIN CHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	53808-1122	53808-1122-1	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A209335-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209335-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209335-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209335-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209335-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209335-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209335-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209335-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209335-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209335-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209335-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209335-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209335-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209335-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209335-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209335-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209335-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209335-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209335-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209335-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209335-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209335-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209335-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209335-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209335-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209335-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209335-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209335-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209335-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209335-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209335-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209335-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209335-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209335-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209335-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209335-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209335-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209335-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209335-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209335-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209335-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209335-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1122-1	2024-01-30	C162847	48780-1	1030e365-0457-111a-e063-dadaa90a10e2	OXYBUTYNIN CHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1122-1	Oxybutynin Chloride	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1122	OXYBUTYNIN CHLORIDE TABLET [DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20190123_8189da24-31df-428f-bae5-b249779a9057.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	REMEDYREPACK INC.	1a08a16a-f16d-4ef1-95bb-6943bcae0737	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Preferred Pharmaceuticals Inc.	0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	13a79659-a181-6a61-e063-6294a90ae034	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	9c8ced4b-94de-4df8-bea3-b42b8846b769	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	0c021aad-97a3-4404-a11e-cdd2ec731c6b	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f92cf6d0-5f49-40e2-a4f4-8ff377cacbfb	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	KVK-Tech, Inc.	f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	39a2d144-0c10-4aec-9fa4-0adc24b332eb	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L9F3D9RENQ	OXYBUTYNIN CHLORIDE	1508-65-2	OXYBUTYNIN CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863664	oxyBUTYnin chloride 5 MG Oral Tablet	PSN	8189da24-31df-428f-bae5-b249779a9057	1
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	8189da24-31df-428f-bae5-b249779a9057	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53808-1122-1	53808112201	30 TABLET in 1 BLISTER PACK (53808-1122-1)	30 tablet	2018-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS, USP Rx only	DOH CENTRAL PHARMACY	2019-01-22	HUMAN PRESCRIPTION DRUG LABEL	1