OXYBUTYNIN CHLORIDE

Product NDC
63629-5484
11-digit product format
636295484
Labeler code
63629
Product ID
63629-5484_70b1403e-beae-4720-8028-4ee34481f74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076745
Marketing category
ANDA
Marketing start
2007-05-11
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-5484IInactivated by FDA2026-08-17
excluded packagepackage63629-548463629-5484-1IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-5484-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-5484-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-5484-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-5484-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-5484-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-5484-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-5484-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-5484-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-5484-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-5484-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-5484-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-5484-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-5484-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-5484-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-5484-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63629-5484-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63629-5484-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63629-5484-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-5484-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-5484-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-5484-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-5484-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076745-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09
A076745-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09
A076745-003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076745-002OXYBUTYNIN CHLORIDE5MGTABLET, EXTENDED RELEASE / ORAL2007-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076745-003OXYBUTYNIN CHLORIDE10MGTABLET, EXTENDED RELEASE / ORAL2007-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076745-001OXYBUTYNIN CHLORIDE15MGTABLET, EXTENDED RELEASE / ORAL2006-11-091e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076745-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076745-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076745-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076745-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076745-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076745-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076745-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076745-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076745-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076745-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076745-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076745-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5484-1OXYBUTYNIN CHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301001

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5484OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001Legacy NDC, 1 package rows20150325_b9090682-ea78-4f3e-9b07-c97d119d264b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNb9090682-ea78-4f3e-9b07-c97d119d264b1001
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDb9090682-ea78-4f3e-9b07-c97d119d264b1001
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYb9090682-ea78-4f3e-9b07-c97d119d264b1001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63629-5484-16362954840130 in 1 BOTTLEHistorical