Oxybutynin Chloride

Product NDC: 70404-006
11-digit product format: 704040006
Labeler code: 70404
Product ID: 70404-006_9c56006a-a791-e6af-e053-2995a90a3fc9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxybutynin chloride
Dosage form: TABLET
Route: ORAL
Labeler: Tulex Pharmaceuticals, Inc.
Application: ANDA210125
Marketing category: ANDA
Marketing start: 2017-01-01
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210125-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2018-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210125-001	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 · 41 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	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210125-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2018-09-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A210125-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210125-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210125-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210125-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210125-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210125-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210125-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210125-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210125-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210125-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210125-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210125-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210125-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210125-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210125-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210125-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210125-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210125-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210125-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210125-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210125-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210125-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210125-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210125-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210125-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210125-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210125-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210125-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210125-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210125-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210125-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210125-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210125-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210125-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210125-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210125-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210125-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210125-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210125-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210125-001	AB	1	`cb3db0bc1861…`

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	TruPharma LLC	7c497c6c-2448-2c80-e053-2991aa0ab8c7	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210125 application number: ANDA210125
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e1c1043-e4c5-4a06-9cc1-45d4397746f4	2023-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210125 application number: ANDA210125

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L9F3D9RENQ	OXYBUTYNIN CHLORIDE	1508-65-2	OXYBUTYNIN CHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP	Tulex Pharmaceuticals, Inc.	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	5

Oxybutynin Chloride

Orange Book products#

Therapeutic equivalence codes#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#