FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
0615-8428
11-digit product format
006158428
Labeler code
0615
Product ID
0615-8428_06081cba-ac29-4db7-9504-463425b03ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075079
Marketing category
ANDA
Marketing start
2022-04-04
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8428DDiscontinued by firm2026-07-31
excluded packagepackage0615-84280615-8428-05DDiscontinued by firm2026-07-31
excluded packagepackage0615-84280615-8428-39DDiscontinued 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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8428-390061584283930 TABLET in 1 BLISTER PACK (0615-8428-39) 30 tablet2022-07-150000-00-00NoNoCurrent