Oxybutynin Chloride

Product NDC: 55154-2632
11-digit product format: 551542632
Labeler code: 55154
Product ID: 55154-2632_10f1f9c9-8e11-4c53-889c-a6a6875c202f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA209823
Marketing category: ANDA
Marketing start: 2024-10-21
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxybutynin Chloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN CHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L9F3D9RENQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863664	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8455b543-81ce-4522-ae9b-8396f944945c	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-2632-0	Oxybutynin Chloride	1 in 1 BLISTER PACK	TABLET	1		3
55154-2632-0	Oxybutynin Chloride	10 in 1 BAG	TABLET	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2632	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH 107, LLC]	2	Current NDC, 2 package rows	20250108_8455b543-81ce-4522-ae9b-8396f944945c.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 ndc (product): 55154-2632
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	8455b543-81ce-4522-ae9b-8396f944945c	3
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	8455b543-81ce-4522-ae9b-8396f944945c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2632-0	55154263200	10 BLISTER PACK in 1 BAG (55154-2632-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2024-10-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP Rx only	Cardinal Health 107, LLC	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	3