Home NDC 64380-190 Oxybutynin Chloride
Product NDC 64380-190
11-digit product format 643800190
Labeler code 64380
Product ID 64380-190_289e5f8b-6604-47a3-a3af-e2309972ba7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxybutynin chloride
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA075079
Marketing category ANDA
Marketing start 2026-04-10
Substance OXYBUTYNIN CHLORIDE
Active strength 2.5 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075079-001 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 A075079-002 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 2.5MG TABLET / ORAL AB 2026-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A075079-001 OXYBUTYNIN CHLORIDE 5MG TABLET / ORAL AB 1997-10-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A075079-002 OXYBUTYNIN CHLORIDE 2.5MG TABLET / ORAL AB 2026-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A075079-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A075079-002 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Oxybutynin Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBUTYNIN CHLORIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L9F3D9RENQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863664 Internal RxNorm lookup 863758 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-190-01 Oxybutynin Chloride 100 in 1 BOTTLE TABLET 100 6
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64380-190-01 64380019001 100 TABLET in 1 BOTTLE (64380-190-01) 100 tablet 2026-04-10 No No Current