Oxybutynin Chloride

Product NDC
70518-2640
Requested package NDC
70518-2640-2
11-digit product format
705182640
Labeler code
70518
Product ID
70518-2640_4a7c6cdc-4b20-7a2a-e063-6294a90aaea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209335
Marketing category
ANDA
Marketing start
2020-03-26
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
2027-12-31
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 packagepackage70518-264070518-2640-2DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

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
A209335-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209335-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22e64feba35796…

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
2026-08-18 06:07:402026-07A209335-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209335-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209335-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209335-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209335-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209335-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209335-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209335-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209335-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209335-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209335-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209335-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209335-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209335-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209335-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209335-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209335-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209335-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209335-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209335-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209335-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209335-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209335-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209335-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209335-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209335-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209335-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209335-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209335-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209335-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209335-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209335-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209335-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209335-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209335-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209335-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209335-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209335-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209335-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209335-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

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
1a08a16a-f16d-4ef1-95bb-6943bcae0737Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2640-0Oxybutynin Chloride30 in 1 BLISTER PACKTABLET309
70518-2640-1Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET609
70518-2640-2Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET909
70518-2640-3Oxybutynin Chloride180 in 1 BOTTLE, PLASTICTABLET1809
70518-2640-4Oxybutynin Chloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2640OXYBUTYNIN CHLORIDE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250104_1a08a16a-f16d-4ef1-95bb-6943bcae0737.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEREMEDYREPACK INC.1a08a16a-f16d-4ef1-95bb-6943bcae07372026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
ndc (package): 70518-2640-2
ndc (product): 70518-2640
ndc11 (package): 70518264002
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPreferred Pharmaceuticals Inc.0e002fe8-fa3f-4a7d-84df-0c6e031e6ae42026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLC13a79659-a181-6a61-e063-6294a90ae0342025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.9c8ced4b-94de-4df8-bea3-b42b8846b7692025-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.0c021aad-97a3-4404-a11e-cdd2ec731c6b2025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepackf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEKVK-Tech, Inc.f99fdfe8-a980-4a72-bc99-aa2ce0bdfd862024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209335
application number: ANDA209335

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxybutynin chloride 5 MG Oral TabletSCD1a08a16a-f16d-4ef1-95bb-6943bcae07379

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2640-27051826400290 TABLET in 1 BOTTLE, PLASTIC (70518-2640-2) 90 tablet2020-06-110000-00-00NoNoCurrent