Oxybutynin Chloride

Product NDC: 42291-914
11-digit product format: 422910914
Labeler code: 42291
Product ID: 42291-914_e9e61f3d-53da-64e0-e053-2995a90aad21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxybutynin chloride
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA075079
Marketing category: ANDA
Marketing start: 2022-09-30
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: 2023-12-31
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	42291-914		D	Discontinued by firm		2026-08-03
excluded package	package	42291-914	42291-914-50	D	Discontinued by firm		2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075079-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31
A075079-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075079-001	AB
A075079-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`cb3db0bc1861…`

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
2026-02-19 14:30 UTC	2026-02	A075079-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	AB	1	`cb3db0bc1861…`

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	Strides Pharma Science Limited	9ede5def-d185-4e40-9c10-8663ac654caf	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2425f49f-ade3-5178-e063-6294a90adfac	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-914-50	EA - Each	42291-914	be0eeeec-0664-4325-ba46-fd40b2397044	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-914	OXYBUTYNIN CHLORIDE TABLET [AVKARE]	2	Legacy NDC	20240111_e9e61a32-d815-2fa3-e053-2a95a90a63ee.zip

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	2425f49f-ade3-5178-e063-6294a90adfac	1
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	2425f49f-ade3-5178-e063-6294a90adfac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-914-50	42291091450	500 TABLET in 1 BOTTLE (42291-914-50)	500 tablet	2022-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP Rx Only	AvKARE	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
Oxybutynin Chloride Tablets, USP Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	1