Oxybutynin Chloride

Product NDC
71610-394
11-digit product format
716100394
Labeler code
71610
Product ID
71610-394_7dee4b0d-3071-4962-82b6-0b0ff220f91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210125
Marketing category
ANDA
Marketing start
2019-01-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
L9F3D9RENQOXYBUTYNIN CHLORIDE1508-65-2OXYBUTYNIN CHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-394-537161003945360 TABLET in 1 BOTTLE, PLASTIC (71610-394-53) 60 tablet2020-02-05NoNoHistorical
71610-394-607161003946090 TABLET in 1 BOTTLE, PLASTIC (71610-394-60) 90 tablet2020-02-05NoNoHistorical
71610-394-8071610039480180 TABLET in 1 BOTTLE, PLASTIC (71610-394-80) 180 tablet2022-12-30NoNoHistorical
71610-394-9271610039492270 TABLET in 1 BOTTLE, PLASTIC (71610-394-92) 270 tablet2020-02-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxybutynin Chloride Tablets, USP (PLD)Aphena Pharma Solutions - Tennessee, LLC2023-01-04HUMAN PRESCRIPTION DRUG LABEL3