FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
70518-2640
Requested package NDC
70518-2640-3
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-264070518-2640-3DDiscontinued by firm2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209335-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB2017-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209335-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 70518-2640-3
ndc (product): 70518-2640
ndc11 (package): 70518264003
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

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 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2640-02022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-02022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-02022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-02022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only

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

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
70518-2640-370518264003180 TABLET in 1 BOTTLE, PLASTIC (70518-2640-3) 180 tablet2020-06-110000-00-00NoNoCurrent