Oxybutynin Chloride

Product NDC: 67544-569
11-digit product format: 675440569
Labeler code: 67544
Product ID: 67544-569_7c8f8413-4c41-4f54-9530-46f64782ced0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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: 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-569		D	Discontinued by firm	2026-08-07
excluded package	package	67544-569	67544-569-53	D	Discontinued by firm	2026-08-07
excluded package	package	67544-569	67544-569-60	D	Discontinued by firm	2026-08-07
excluded package	package	67544-569	67544-569-80	D	Discontinued by firm	2026-08-07
excluded package	package	67544-569	67544-569-92	D	Discontinued by firm	2026-08-07

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-569-53	EA - Each	67544-569	acce3e17-af28-48ef-9166-a47bd81adb4a	1	2017-12-14
67544-569-60	EA - Each	67544-569	aca3d0bf-10f9-4f60-bf3a-13af5bc208d9	1	2017-12-14
67544-569-80	EA - Each	67544-569	d2876c14-bd63-4a8f-b317-8bd9be72139f	1	2017-12-14
67544-569-92	EA - Each	67544-569	be96b926-bc5f-46f1-a8c7-834e78c27093	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-569	OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20171213_a16a5f0e-ae29-4b56-81a8-aa9398902a73.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 · 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
67544-569-53	67544056953	60 TABLET in 1 BOTTLE (67544-569-53)	60 tablet	2015-08-03	0000-00-00	No	No	Current
67544-569-60	67544056960	90 TABLET in 1 BOTTLE (67544-569-60)	90 tablet	2009-02-03	0000-00-00	No	No	Current
67544-569-92	67544056992	270 TABLET in 1 BOTTLE (67544-569-92)	270 tablet	2015-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS USP	Aphena Pharma Solutions - Tennessee, LLC	2009-02-03	HUMAN PRESCRIPTION DRUG LABEL	1