Oxybutynin Chloride

Product NDC
0832-0038
Requested package NDC
0832-0038-01
11-digit product format
008320038
Labeler code
0832
Product ID
0832-0038_45af3420-b44f-39a1-e063-6394a90ad626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA074625
Marketing category
ANDA
Marketing start
2011-11-07
Marketing end
2028-12-31
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0832-00380832-0038-01DDiscontinued by firm2026-08-07

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074625-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074625-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074625-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1996-07-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074625-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074625-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074625-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074625-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074625-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074625-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074625-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074625-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074625-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074625-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074625-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074625-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074625-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074625-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074625-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074625-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074625-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074625-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074625-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074625-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074625-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074625-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074625-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074625-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074625-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074625-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074625-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074625-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074625-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074625-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074625-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074625-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074625-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074625-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074625-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074625-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074625-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074625-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074625-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074625-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L9F3D9RENQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863664Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ee6835a-7a7d-49a9-8460-2f1dd270ead3Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0038-00Oxybutynin Chloride100 in 1 BOTTLETABLET10017
0832-0038-01Oxybutynin Chloride100 in 1 CARTONTABLET10017
0832-0038-10Oxybutynin Chloride1000 in 1 BOTTLETABLET100017
0832-0038-50Oxybutynin Chloride500 in 1 BOTTLETABLET50017
0832-0038-89Oxybutynin Chloride1 in 1 BLISTER PACKTABLET117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0038-00EA - Each0832-0038f3763031-4e45-4646-a8ba-3d7de1546c3512012-07-24
0832-0038-01EA - Each0832-00381d2f3647-37a1-426a-948e-97432f95886d12018-06-11
0832-0038-10EA - Each0832-0038177cafb0-d308-4e31-89b9-4595cb6ea70e12012-07-24
0832-0038-50EA - Each0832-003845fb36e1-d85b-47fb-970b-be7fd4528abb12012-07-24
0832-0038-89EA - Each0832-0038ebc21517-3bb5-4b5e-a6ad-415af411acff12018-06-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0038OXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]15Current NDC, Legacy NDC, 5 package rows20230921_3ee6835a-7a7d-49a9-8460-2f1dd270ead3.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEUpsher-Smith Laboratories, LLC3ee6835a-7a7d-49a9-8460-2f1dd270ead32025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074625
application number: ANDA074625
ndc (package): 0832-0038-01
ndc (product): 0832-0038
ndc11 (package): 00832003801
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074625
application number: ANDA074625

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN3ee6835a-7a7d-49a9-8460-2f1dd270ead317
863664oxybutynin chloride 5 MG Oral TabletSCD3ee6835a-7a7d-49a9-8460-2f1dd270ead317
863664oxyBUTYnin chloride 5 MG Oral TabletPSN4eb9441b-27ba-1b8f-e054-00144ff88e883
863664oxybutynin chloride 5 MG Oral TabletSCD4eb9441b-27ba-1b8f-e054-00144ff88e883
863664oxyBUTYnin chloride 5 MG Oral TabletPSN58136f28-70c1-4cf2-bcd7-858c5609431a1
863664oxyBUTYnin chloride 5 MG Oral TabletPSN841eea91-2112-4940-868d-25ef085e8c761
863664oxyBUTYnin chloride 5 MG Oral TabletPSNc687e86b-1dc2-4f9c-a032-30f626f54d901
863664oxybutynin chloride 5 MG Oral TabletSCD58136f28-70c1-4cf2-bcd7-858c5609431a1
863664oxybutynin chloride 5 MG Oral TabletSCD841eea91-2112-4940-868d-25ef085e8c761
863664oxybutynin chloride 5 MG Oral TabletSCDc687e86b-1dc2-4f9c-a032-30f626f54d901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0038-0100832003801100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89) 100 blister pack2018-03-152026-07-31NoNoCurrent