OXYBUTYNIN CHLORIDE

Product NDC: 71335-1014
11-digit product format: 713351014
Labeler code: 71335
Product ID: 71335-1014_d8012174-1a1c-46d9-9e97-094e9462a1f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYBUTYNIN CHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209025
Marketing category: ANDA
Marketing start: 2018-02-01
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 · 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: 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
f26e590d-956e-493b-a6ac-6056aeeaf411	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
71335-1014-1	OXYBUTYNIN CHLORIDE	30 in 1 BOTTLE	TABLET	30	5
71335-1014-2	OXYBUTYNIN CHLORIDE	100 in 1 BOTTLE	TABLET	100	5
71335-1014-3	OXYBUTYNIN CHLORIDE	20 in 1 BOTTLE	TABLET	20	5
71335-1014-4	OXYBUTYNIN CHLORIDE	60 in 1 BOTTLE	TABLET	60	5
71335-1014-5	OXYBUTYNIN CHLORIDE	90 in 1 BOTTLE	TABLET	90	5
71335-1014-6	OXYBUTYNIN CHLORIDE	42 in 1 BOTTLE	TABLET	42	5
71335-1014-7	OXYBUTYNIN CHLORIDE	15 in 1 BOTTLE	TABLET	15	5
71335-1014-8	OXYBUTYNIN CHLORIDE	180 in 1 BOTTLE	TABLET	180	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1014	OXYBUTYNIN CHLORIDE TABLET [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 8 package rows	20240823_f26e590d-956e-493b-a6ac-6056aeeaf411.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 · 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
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 ndc (product): 71335-1014
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	f26e590d-956e-493b-a6ac-6056aeeaf411	5
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	f26e590d-956e-493b-a6ac-6056aeeaf411	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1014-1	71335101401	30 TABLET in 1 BOTTLE (71335-1014-1)	30 tablet	2018-11-21	0000-00-00	No	No	Current
71335-1014-2	71335101402	100 TABLET in 1 BOTTLE (71335-1014-2)	100 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-3	71335101403	20 TABLET in 1 BOTTLE (71335-1014-3)	20 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-4	71335101404	60 TABLET in 1 BOTTLE (71335-1014-4)	60 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-5	71335101405	90 TABLET in 1 BOTTLE (71335-1014-5)	90 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-6	71335101406	42 TABLET in 1 BOTTLE (71335-1014-6)	42 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-7	71335101407	15 TABLET in 1 BOTTLE (71335-1014-7)	15 tablet	2024-08-09	0000-00-00	No	No	Current
71335-1014-8	71335101408	180 TABLET in 1 BOTTLE (71335-1014-8)	180 tablet	2024-08-09	0000-00-00	No	No	Current