Oxybutynin Chloride

Product NDC: 0904-6570
11-digit product format: 009046570
Labeler code: 0904
Product ID: 0904-6570_4eb0d216-64dc-4192-88c1-39b134612e37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA204010
Marketing category: ANDA
Marketing start: 2015-11-02
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204010-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23
A204010-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23
A204010-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204010-001	AB
A204010-002	AB
A204010-003	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 4 · 123 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	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204010-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-11-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A204010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204010-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204010-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204010-001	AB	1	`8072bd15b7f6…`

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
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
7688cce8-797d-454c-95fb-52689741582e	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	SPL version
0904-6570-04	Oxybutynin Chloride	30 in 1 CARTON	TABLET, EXTENDED RELEASE	30	10
0904-6570-04	Oxybutynin Chloride	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1	10
0904-6570-06	Oxybutynin Chloride	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1	10
0904-6570-06	Oxybutynin Chloride	50 in 1 CARTON	TABLET, EXTENDED RELEASE	50	10
0904-6570-61	Oxybutynin Chloride	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1	10
0904-6570-61	Oxybutynin Chloride	100 in 1 CARTON	TABLET, EXTENDED RELEASE	100	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6570-04	EA - Each	0904-6570	c298e0ed-fb2d-4e65-b824-a790a6002dfb	1	2018-08-13
0904-6570-06	EA - Each	0904-6570	49a949e8-c44c-49ec-99d2-648db55da051	1	2016-11-08
0904-6570-61	EA - Each	0904-6570	5c6447fd-d461-4bcd-b3c9-e7b1359c724f	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6570	OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 6 package rows	20250206_7688cce8-797d-454c-95fb-52689741582e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7688cce8-797d-454c-95fb-52689741582e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204010 application number: ANDA204010 ndc (product): 0904-6570
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Amneal Pharmaceuticals LLC	53924eba-1919-4203-9a1e-d57dfdd3b963	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204010 application number: ANDA204010

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
863636	oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet	PSN	7688cce8-797d-454c-95fb-52689741582e	10
863636	24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet	SCD	7688cce8-797d-454c-95fb-52689741582e	10
863636	oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet	SY	7688cce8-797d-454c-95fb-52689741582e	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6570-04	00904657004	30 BLISTER PACK in 1 CARTON (0904-6570-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	30 blister pack	2015-11-02	0000-00-00	No	No	Current
0904-6570-06	00904657006	50 BLISTER PACK in 1 CARTON (0904-6570-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	50 blister pack	2015-11-02	0000-00-00	No	No	Current
0904-6570-61	00904657061	100 BLISTER PACK in 1 CARTON (0904-6570-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	2015-11-02	0000-00-00	No	No	Current