Oxybutynin Chloride

Product NDC: 71610-277
11-digit product format: 716100277
Labeler code: 71610
Product ID: 71610-277_b28dba2b-b19b-469e-98d8-54e87e3800e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA209823
Marketing category: ANDA
Marketing start: 2017-10-23
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 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23	`caaa826d4ba7…`
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…`

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
2026-08-18 06:07:40	2026-07	A209823-001	AB	1	`caaa826d4ba7…`
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…`

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
d2bb6927-5fbf-49ca-a891-d701bff1c812	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
71610-277-30	Oxybutynin Chloride	30 in 1 BOTTLE	TABLET	30	2
71610-277-53	Oxybutynin Chloride	60 in 1 BOTTLE	TABLET	60	2
71610-277-60	Oxybutynin Chloride	90 in 1 BOTTLE	TABLET	90	2
71610-277-80	Oxybutynin Chloride	180 in 1 BOTTLE	TABLET	180	2
71610-277-92	Oxybutynin Chloride	270 in 1 BOTTLE	TABLET	270	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-277-30	EA - Each	71610-277	bbeea2ab-e614-4063-972c-6fdea3a3b4df	1	2023-07-06
71610-277-53	EA - Each	71610-277	6fc0a6e0-7985-471d-a7f8-0c2337e347bf	1	2019-07-02
71610-277-60	EA - Each	71610-277	e494e17d-cc4f-43a4-80e2-3eef13849a62	1	2019-07-02
71610-277-80	EA - Each	71610-277	109811a7-f4fc-42c9-bbea-2b5ece1a304f	1	2019-07-02
71610-277-92	EA - Each	71610-277	174755aa-35bf-458a-88c9-53446d431200	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-277	OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 5 package rows	20230602_d2bb6927-5fbf-49ca-a891-d701bff1c812.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
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 ndc (product): 71610-277

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	d2bb6927-5fbf-49ca-a891-d701bff1c812	2
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	d2bb6927-5fbf-49ca-a891-d701bff1c812	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-277-30	71610027730	30 TABLET in 1 BOTTLE (71610-277-30)	30 tablet	2023-05-31		No	No	Current
71610-277-53	71610027753	60 TABLET in 1 BOTTLE (71610-277-53)	60 tablet	2019-05-13	0000-00-00	No	No	Current
71610-277-60	71610027760	90 TABLET in 1 BOTTLE (71610-277-60)	90 tablet	2019-05-13	0000-00-00	No	No	Current
71610-277-80	71610027780	180 TABLET in 1 BOTTLE (71610-277-80)	180 tablet	2019-05-13	0000-00-00	No	No	Current
71610-277-92	71610027792	270 TABLET in 1 BOTTLE (71610-277-92)	270 tablet	2019-05-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL	2