Oxybutynin Chloride

Product NDC: 10135-640
11-digit product format: 101350640
Labeler code: 10135
Product ID: 10135-640_76849892-9485-4e00-990b-81e7dcc2fca1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA209823
Marketing category: ANDA
Marketing start: 2018-04-01
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-640		I	Inactivated by FDA	2026-08-07
excluded package	package	10135-640	10135-640-01	I	Inactivated by FDA	2026-08-07
excluded package	package	10135-640	10135-640-05	I	Inactivated by FDA	2026-08-07
excluded package	package	10135-640	10135-640-10	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 2 · 76 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	10135-640-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-640-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-640-05	`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	10135-640-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-640-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-640-05	`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	10135-640-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-640-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-640-05	`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	10135-640-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-640-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-640-05	`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	10135-640-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-640-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-640-05	`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	10135-640-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-640-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-640-05	`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	10135-640-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-640-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-640-05	`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	10135-640-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-640-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-640-05	`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	10135-640-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-640-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-640-05	`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	10135-640-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-640-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-640-05	`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	10135-640-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-640-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-640-05	`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	10135-640-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-640-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-640-05	`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	10135-640-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-640-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-640-05	`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	10135-640-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-640-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-640-05	`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	10135-640-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-640-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-640-05	`1332a3947898…`	`d4bfe170f9cd…`

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
A209823-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209823-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`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	A209823-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209823-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209823-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209823-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209823-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209823-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209823-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209823-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209823-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209823-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209823-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209823-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209823-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209823-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209823-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209823-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209823-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209823-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209823-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209823-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209823-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209823-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209823-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209823-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209823-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209823-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209823-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209823-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209823-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209823-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209823-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209823-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209823-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209823-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209823-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209823-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209823-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209823-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209823-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209823-001	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
10135-640-01	2021-01-29	C162847	48780-1	ba0f9c33-3eac-a910-e053-dadaa90a0b85	Oxybutynin Chloride Tablets
10135-640-05	2021-01-29	C162847	48780-1	ba0f9c33-3eac-a910-e053-dadaa90a0b85	Oxybutynin Chloride Tablets
10135-640-10	2021-01-29	C162847	48780-1	ba0f9c33-3eac-a910-e053-dadaa90a0b85	Oxybutynin Chloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-640-01	Oxybutynin Chloride	100 in 1 BOTTLE	TABLET	100	2
10135-640-05	Oxybutynin Chloride	500 in 1 BOTTLE	TABLET	500	2
10135-640-10	Oxybutynin Chloride	1000 in 1 BOTTLE	TABLET	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-640-01	EA - Each	10135-640	b420df7f-388e-412e-8367-9047ea4dfb86	1	2018-05-09
10135-640-05	EA - Each	10135-640	59240efb-a0cc-4285-86ae-5f82e969ef28	1	2018-05-09
10135-640-10	EA - Each	10135-640	0931881e-8018-4935-b429-8c61b06b9cc5	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-640	OXYBUTYNIN CHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]	2	Legacy NDC, 3 package rows	20191112_97f3f988-6bf1-453c-9be2-6671119a6f0b.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	f330b7a0-bbe0-0f00-e053-2a95a90a37b8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	VERITYRX, LLC	427b6ffb-3ff4-932f-e063-6394a90ae8b9	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7769ad3d-6228-4b2d-8f44-4efe990d3fad	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Cardinal Health 107, LLC	8455b543-81ce-4522-ae9b-8396f944945c	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Golden State Medical Supply, Inc.	6f409d7f-b064-1363-e053-2a91aa0a3a14	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	ANI Pharmaceuticals, Inc.	3b1f5585-9b33-4a96-bf33-8e6bab14bf0c	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	NuCare Pharmaceuticals,Inc.	8e830697-a6d3-13ed-e053-2995a90acb11	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	5e3b454b-6d3c-418b-8ac2-b0e17f018bbf	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	afc6a3aa-e43d-4f10-bdbd-570a149bf9db	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d2bb6927-5fbf-49ca-a891-d701bff1c812	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823

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	97f3f988-6bf1-453c-9be2-6671119a6f0b	2
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	97f3f988-6bf1-453c-9be2-6671119a6f0b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-640-01	10135064001	100 in 1 BOTTLE	Historical
10135-640-05	10135064005	500 in 1 BOTTLE	Historical
10135-640-10	10135064010	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets	Marlex Pharmaceuticals Inc	2019-10-18	HUMAN PRESCRIPTION DRUG LABEL	2