FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71610-860
Requested package NDC
71610-860-30
11-digit product format
716100860
Labeler code
71610
Product ID
71610-860_2425de26-9d88-2a5d-e063-6294a90acaa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075079
Marketing category
ANDA
Marketing start
2022-09-30
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
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075079-001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1997-10-31
A075079-002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE2.5MGTABLET / ORALAB2026-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075079-001AB
A075079-002AB

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 22:54:322026-06A075079-001OXYBUTYNIN CHLORIDE5MGTABLET / ORALAB1997-10-31a50c72e98297…
2026-08-01 22:54:322026-06A075079-002OXYBUTYNIN CHLORIDE2.5MGTABLET / ORALAB2026-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075079-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075079-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limited9ede5def-d185-4e40-9c10-8663ac654caf2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075079
application number: ANDA075079
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC2425f49f-ade3-5178-e063-6294a90adfac2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075079
application number: ANDA075079
ndc (package): 71610-860-30
ndc (product): 71610-860
ndc11 (package): 71610086030

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2026-12-31

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
2425f49f-ade3-5178-e063-6294a90adfacAvailable 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
71610-860-30Oxybutynin Chloride30 in 1 BOTTLETABLET301
71610-860-53Oxybutynin Chloride60 in 1 BOTTLETABLET601
71610-860-60Oxybutynin Chloride90 in 1 BOTTLETABLET901
71610-860-80Oxybutynin Chloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-860-30EA - Each71610-860f43421cc-e703-4255-a85a-8f4f670df8de12024-12-10
71610-860-53EA - Each71610-86002df5982-ca37-46d7-a13c-efe008a01b5b12024-12-10
71610-860-60EA - Each71610-860286908a6-3215-4837-93fe-069d1008902312024-12-10
71610-860-80EA - Each71610-860ad22a57d-f8e0-4e97-9e3c-5c0decf84f2412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-860OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20241017_2425f49f-ade3-5178-e063-6294a90adfac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN2425f49f-ade3-5178-e063-6294a90adfac1
863664oxybutynin chloride 5 MG Oral TabletSCD2425f49f-ade3-5178-e063-6294a90adfac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-860-307161008603030 TABLET in 1 BOTTLE (71610-860-30) 30 tablet2024-10-10NoNoCurrent