OXYBUTYNIN CHLORIDE

Product NDC: 64980-679
11-digit product format: 649800679
Labeler code: 64980
Product ID: 64980-679_9578b6b8-5b9d-4263-9142-39b2c7216b85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYBUTYNIN CHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: RISING PHARMA HOLDINGS, INC.
Application: ANDA209025
Marketing category: ANDA
Marketing start: 2026-04-27
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: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209025-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21
A209025-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB	RS	2023-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209025-001	AB
A209025-002	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 · 64 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	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`b00525d2431f…`

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	A209025-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209025-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209025-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209025-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209025-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209025-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209025-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209025-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209025-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209025-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209025-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209025-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209025-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209025-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209025-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209025-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209025-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209025-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209025-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209025-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209025-001	AB	1	`cb3db0bc1861…`

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	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
9578b6b8-5b9d-4263-9142-39b2c7216b85	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
64980-679-01	OXYBUTYNIN CHLORIDE	100 in 1 BOTTLE	TABLET	100	1
64980-679-10	OXYBUTYNIN CHLORIDE	1000 in 1 BOTTLE	TABLET	1000	1
64980-679-50	OXYBUTYNIN CHLORIDE	500 in 1 BOTTLE	TABLET	500	1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	9578b6b8-5b9d-4263-9142-39b2c7216b85	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025 ndc (product): 64980-679
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	44990ed6-b8e7-40f5-b636-e848024ec6d8	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	0697b3cf-b146-47c0-b5a5-5905ae8d1c97	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	8bd5dce0-d56a-4e64-8de7-e7cd7775526b	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	3a319017-4e25-402e-8ba0-63b9f1eb707e	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f26e590d-956e-493b-a6ac-6056aeeaf411	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	f8ed80f2-6c3d-4d7f-b761-c2447973c1f9	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025

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	9578b6b8-5b9d-4263-9142-39b2c7216b85	1
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	9578b6b8-5b9d-4263-9142-39b2c7216b85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-679-01	64980067901	100 TABLET in 1 BOTTLE (64980-679-01)	100 tablet	2026-04-27	No	No	Current
64980-679-10	64980067910	1000 TABLET in 1 BOTTLE (64980-679-10)	1000 tablet	2026-04-27	No	No	Current
64980-679-50	64980067950	500 TABLET in 1 BOTTLE (64980-679-50)	500 tablet	2026-04-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS, USP	RISING PHARMA HOLDINGS, INC. \| Piramal Pharma Limited	2026-07-21	Human Prescription Drug Label	2