Oxybutynin Chloride

Product NDC: 53808-0873
11-digit product format: 538080873
Labeler code: 53808
Product ID: 53808-0873_7e123e63-4a3a-4a7a-8b45-e3d5ef102106
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA074625
Marketing category: ANDA
Marketing start: 2013-01-01
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0873		I	Inactivated by FDA		2026-08-07
excluded package	package	53808-0873	53808-0873-2	I	Inactivated by FDA		2026-08-07

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0873-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0873-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0873-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0873-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0873-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0873-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0873-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0873-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0873-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0873-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0873-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0873-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0873-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0873-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0873-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0873-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0873-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0873-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0873-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0873-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0873-2	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A074625-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1996-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074625-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074625-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1996-07-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074625-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074625-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074625-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074625-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074625-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074625-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074625-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074625-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074625-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074625-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074625-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074625-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074625-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074625-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074625-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074625-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074625-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074625-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074625-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074625-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074625-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074625-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074625-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074625-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074625-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074625-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074625-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074625-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074625-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074625-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074625-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074625-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074625-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074625-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074625-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074625-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074625-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074625-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074625-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074625-001	AB	1	`cb3db0bc1861…`

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
53808-0873-2	2020-01-31	C162847	48780-1	9d75b9cf-f773-f424-e053-dadaa90a57ce	OXYBUTYNIN CHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0873-2	Oxybutynin Chloride	60 in 1 BLISTER PACK	TABLET	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0873	OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20140415_841eea91-2112-4940-868d-25ef085e8c76.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Upsher-Smith Laboratories, LLC	3ee6835a-7a7d-49a9-8460-2f1dd270ead3	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074625 application number: ANDA074625
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	58136f28-70c1-4cf2-bcd7-858c5609431a	2016-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074625 application number: ANDA074625

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	841eea91-2112-4940-868d-25ef085e8c76	1
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	841eea91-2112-4940-868d-25ef085e8c76	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0873-2	53808087302	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS, USP	State of Florida DOH Central Pharmacy	2013-09-26	HUMAN PRESCRIPTION DRUG LABEL	1