Oxybutynin Chloride

Product NDC: 68084-400
Requested package NDC: 68084-400-01
11-digit product format: 680840400
Labeler code: 68084
Product ID: 68084-400_e711c86c-6f55-564d-e053-2995a90ad0e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxybutynin chloride
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075079
Marketing category: ANDA
Marketing start: 2009-08-20
Marketing end: 2023-06-30
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: 0000-00-00
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	68084-400	68084-400-01	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075079-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31
A075079-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075079-001	AB
A075079-002	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 · 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
2026-02-19 14:30 UTC	2026-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`cb3db0bc1861…`

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	A075079-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075079-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075079-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-400-01	EA - Each	68084-400	41666e81-15c3-4690-94fc-d92d4134a63a	1	2012-07-24
68084-400-11	EA - Each	68084-400	b155c5bf-da98-4fc7-9851-e4e846ffd22d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]	3

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	Strides Pharma Science Limited	9ede5def-d185-4e40-9c10-8663ac654caf	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2425f49f-ade3-5178-e063-6294a90adfac	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079

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
68084-400-01	68084040001	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-400-01) > 1 TABLET in 1 BLISTER PACK (68084-400-11)	100 blister pack	2009-08-20	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxybutynin Chloride Tablets, USP 8240001/0819 Rx only	American Health Packaging	2022-08-25	HUMAN PRESCRIPTION DRUG LABEL	9
Oxybutynin Chloride Tablets, USP 8240001/0218 Rx only	Cardinal Health	2020-09-15	HUMAN PRESCRIPTION DRUG LABEL	9