Oxybutynin Chloride

Product NDC: 68071-1875
Requested package NDC: 68071-1875-7
11-digit product format: 680711875
Labeler code: 68071
Product ID: 68071-1875_bb26cd3c-8b84-cb42-e053-2995a90a049e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxybutynin Chloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA071655
Marketing category: ANDA
Marketing start: 1990-09-30
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-1875	68071-1875-7	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A071655-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1988-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071655-001	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	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`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	A071655-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1875-1	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-2	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-3	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-6	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-7	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-9	2024-07-16	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-1	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-2	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-3	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-6	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-7	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-9	2023-01-30	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-1	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-2	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-3	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-6	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-7	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-9	2021-02-12	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-1	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-2	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-3	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-6	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-7	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP
68071-1875-9	2021-01-29	OXYBUTYNIN CHLORIDE TABLETS USP

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	direct rx	b3d6d2a8-97c4-5bad-e053-2a95a90a155d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	246d2f79-8ab5-4023-9068-1451b695ac16	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Teva Pharmaceuticals USA, Inc.	cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29	2024-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Proficient Rx LP	e3f0c249-8085-4979-823a-820e233a284f	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1875-7	68071187507	270 TABLET in 1 BOTTLE (68071-1875-7)	270 tablet	2017-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYBUTYNIN CHLORIDE TABLETS USP	NuCare Pharmaceuticals, Inc.	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	3