Oxybutynin Chloride

Product NDC: 72888-031
Requested package NDC: 72888-031-01
11-digit product format: 728880031
Labeler code: 72888
Product ID: 72888-031_48596af5-29b7-ab6c-e063-6394a90a1276
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Advagen Pharma Limited
Application: ANDA214415
Marketing category: ANDA
Marketing start: 2020-10-27
Substance: OXYBUTYNIN CHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214415-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27
A214415-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27
A214415-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214415-001	AB
A214415-002	AB
A214415-003	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 3 · 114 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
2026-09-14 22:38:34	2026-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214415-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214415-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214415-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214415-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214415-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214415-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Oxybutynin Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN CHLORIDE	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863619	Internal RxNorm lookup
863628	Internal RxNorm lookup
863636	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
7bd31561-4c76-4c6b-819b-492549886673	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
72888-031-01	Oxybutynin Chloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		8
72888-031-05	Oxybutynin Chloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-031-01	EA - Each	72888-031	36e5672f-adb4-4002-91e3-acb9c9452978	1	2021-06-02
72888-031-05	EA - Each	72888-031	86aa3b1b-6ca8-47d0-ad83-2e2e4e0ea85c	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-031	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [ADVAGEN PHARMA LIMITED]	7	Current NDC, Legacy NDC, 2 package rows	20240713_7bd31561-4c76-4c6b-819b-492549886673.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Advagen Pharma Limited	7bd31561-4c76-4c6b-819b-492549886673	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214415 application number: ANDA214415 ndc (package): 72888-031-01 ndc (product): 72888-031 ndc11 (package): 72888003101

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
863619	oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet	PSN	7bd31561-4c76-4c6b-819b-492549886673	8
863628	oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet	PSN	7bd31561-4c76-4c6b-819b-492549886673	8
863636	oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet	PSN	7bd31561-4c76-4c6b-819b-492549886673	8
863619	24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet	SCD	7bd31561-4c76-4c6b-819b-492549886673	8
863628	24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet	SCD	7bd31561-4c76-4c6b-819b-492549886673	8
863636	24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet	SCD	7bd31561-4c76-4c6b-819b-492549886673	8
863619	oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet	SY	7bd31561-4c76-4c6b-819b-492549886673	8
863628	oxybutynin chloride 15 MG 24 HR Extended Release Oral Tablet	SY	7bd31561-4c76-4c6b-819b-492549886673	8
863636	oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet	SY	7bd31561-4c76-4c6b-819b-492549886673	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-031-01	72888003101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-031-01)	2020-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride	Advagen Pharma Limited \| Rubicon Research Limited	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	8