OXYBUTYNIN CHLORIDE

Product NDC: 69315-182
11-digit product format: 693150182
Labeler code: 69315
Product ID: 69315-182_da4b3e8b-09d1-4ef3-a24a-ef078f13bd92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYBUTYNIN CHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA212798
Marketing category: ANDA
Marketing start: 2019-11-01
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 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
A212798-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2020-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212798-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212798-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212798-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212798-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212798-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212798-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212798-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212798-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212798-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212798-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212798-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212798-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212798-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212798-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212798-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212798-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212798-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212798-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212798-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212798-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212798-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212798-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212798-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212798-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212798-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212798-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212798-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212798-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212798-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212798-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212798-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212798-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212798-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212798-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212798-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212798-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212798-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212798-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212798-001	AB	1	`a50c72e98297…`

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
b73b8338-8045-448f-87a6-3d289227d00e	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
69315-182-01	OXYBUTYNIN CHLORIDE	100 in 1 BOTTLE	TABLET	100	8
69315-182-05	OXYBUTYNIN CHLORIDE	500 in 1 BOTTLE	TABLET	500	8
69315-182-10	OXYBUTYNIN CHLORIDE	1000 in 1 BOTTLE	TABLET	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-182-01	EA - Each	69315-182	e2b1ca77-ddc2-47cc-8804-52e0ee76fa90	1	2021-06-02
69315-182-05	EA - Each	69315-182	d238a9ef-fc0b-48dd-988f-7a58cec97645	1	2021-06-02
69315-182-10	EA - Each	69315-182	12d2538c-22ba-41bb-9e4a-f4196b059a9d	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-182	OXYBUTYNIN CHLORIDE TABLET [LEADING PHARMA, LLC]	8	Current NDC, Legacy NDC, 3 package rows	20220215_b73b8338-8045-448f-87a6-3d289227d00e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Redpharm Drug	fc4cfbe6-a940-41c0-e053-6294a90adb14	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	83522acd-0ecc-46ac-a018-a3205ba096ff	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5b72d34e-ae57-4459-ba2c-3bae8a69c5c1	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Leading Pharma, LLC	b73b8338-8045-448f-87a6-3d289227d00e	2022-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798 ndc (product): 69315-182

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	b73b8338-8045-448f-87a6-3d289227d00e	8
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	b73b8338-8045-448f-87a6-3d289227d00e	8
863664	oxyBUTYnin chloride 5 MG Oral Tablet	PSN	83522acd-0ecc-46ac-a018-a3205ba096ff	3
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	83522acd-0ecc-46ac-a018-a3205ba096ff	3
863664	oxyBUTYnin chloride 5 MG Oral Tablet	PSN	fc4cfbe6-a940-41c0-e053-6294a90adb14	2
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	fc4cfbe6-a940-41c0-e053-6294a90adb14	2
863664	oxyBUTYnin chloride 5 MG Oral Tablet	PSN	5b72d34e-ae57-4459-ba2c-3bae8a69c5c1	1
863664	oxybutynin chloride 5 MG Oral Tablet	SCD	5b72d34e-ae57-4459-ba2c-3bae8a69c5c1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-182-01	69315018201	100 TABLET in 1 BOTTLE (69315-182-01)	100 tablet	2019-11-01	0000-00-00	No	No	Current
69315-182-05	69315018205	500 TABLET in 1 BOTTLE (69315-182-05)	500 tablet	2019-11-01	0000-00-00	No	No	Current
69315-182-10	69315018210	1000 TABLET in 1 BOTTLE (69315-182-10)	1000 tablet	2019-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP	Redpharm Drug	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Oxybutynin Chloride Tablets, USP	REMEDYREPACK INC.	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Oxybutynin Chloride Tablets, USP	A-S Medication Solutions	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Oxybutynin Chloride Tablets, USP	NCS HealthCare of KY, LLC dba Vangard Labs	2023-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Oxybutynin Chloride Tablets, USP	Leading Pharma, LLC \| LIFEPharma FZE	2022-02-14	HUMAN PRESCRIPTION DRUG LABEL	8