Oxybutynin Chloride

Product NDC
10147-0771
11-digit product format
101470771
Labeler code
10147
Product ID
10147-0771_dd53bb2c-67e9-11e9-b425-a7d60099106d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Patriot Pharmaceuticals, LLC
Application
NDA020897
Marketing category
NDA
Marketing start
1999-06-26
Marketing end
2019-11-30
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10147-0771DDiscontinued by firm2026-08-07
excluded packagepackage10147-077110147-0771-0DDiscontinued by firm2026-08-07

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10147-0771-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10147-0771-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10147-0771-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10147-0771-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10147-0771-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10147-0771-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10147-0771-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10147-0771-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10147-0771-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10147-0771-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10147-0771-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10147-0771-0557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020897-001DITROPAN XLOXYBUTYNIN CHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16
N020897-002DITROPAN XLOXYBUTYNIN CHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16
N020897-003DITROPAN XLOXYBUTYNIN CHLORIDE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020897-001DITROPAN XL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N020897-002DITROPAN XL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1998-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020897-001DITROPAN XL5MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020897-002DITROPAN XL10MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020897-001DITROPAN XL5MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020897-002DITROPAN XL10MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020897-001DITROPAN XL5MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020897-002DITROPAN XL10MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020897-003DITROPAN XL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020897-001DITROPAN XL5MGTABLET, EXTENDED RELEASE / ORALRLD1998-12-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020897-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020897-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020897-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020897-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020897-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020897-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020897-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020897-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020897-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020897-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020897-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020897-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020897-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020897-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020897-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020897-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020897-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020897-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020897-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020897-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020897-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020897-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020897-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020897-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020897-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020897-002AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020897-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020897-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020897-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020897-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020897-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N020897-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020897-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N020897-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020897-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020897-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020897-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020897-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020897-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N020897-002AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10147-0771-0EA - Each10147-077194a8647c-65d4-4b20-be90-eb1e72e3553a12015-12-02

DailyMed Socrata Ingredients#