Oxybutynin Chloride

Product NDC: 50090-0318
11-digit product format: 500900318
Labeler code: 50090
Product ID: 50090-0318_a1ff6691-b3fd-41f3-ac10-8ed267622e0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA071655
Marketing category: ANDA
Marketing start: 1990-09-30
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: 2021-12-31
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	50090-0318		D	Discontinued by firm	2026-08-07
excluded package	package	50090-0318	50090-0318-0	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0318	50090-0318-1	D	Discontinued by firm	2026-08-07
excluded package	package	50090-0318	50090-0318-3	D	Discontinued by firm	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 · 8 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	50090-0318-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0318-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0318-0	`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	50090-0318-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0318-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0318-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A071655-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1988-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071655-001	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	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`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	A071655-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0318-0	2023-06-27	OXYBUTYNIN CHLORIDE TABLETS USP
50090-0318-1	2023-06-27	OXYBUTYNIN CHLORIDE TABLETS USP
50090-0318-3	2023-06-27	OXYBUTYNIN CHLORIDE TABLETS USP
50090-0318-0	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
50090-0318-1	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
50090-0318-3	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0318-0	EA - Each	50090-0318	b06fa9e5-5815-42b6-83a6-c4a962cd7f10	1	2018-09-05
50090-0318-1	EA - Each	50090-0318	f1b47298-bb5a-4439-b56e-62b18c42477d	1	2018-09-05
50090-0318-3	EA - Each	50090-0318	158da191-9668-403c-8a27-270de292f73e	1	2018-09-05

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	direct rx	b3d6d2a8-97c4-5bad-e053-2a95a90a155d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	246d2f79-8ab5-4023-9068-1451b695ac16	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Teva Pharmaceuticals USA, Inc.	cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29	2024-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Proficient Rx LP	e3f0c249-8085-4979-823a-820e233a284f	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0318-0	50090031800	30 TABLET in 1 BOTTLE (50090-0318-0)	30 tablet	2016-06-29	0000-00-00	No	No	Current
50090-0318-1	50090031801	100 TABLET in 1 BOTTLE (50090-0318-1)	100 tablet	2016-06-29	0000-00-00	No	No	Current
50090-0318-3	50090031803	90 TABLET in 1 BOTTLE (50090-0318-3)	90 tablet	2017-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS USP	A-S Medication Solutions	2023-06-27	HUMAN PRESCRIPTION DRUG LABEL	14