OXYBUTYNIN CHLORIDE

Product NDC
64980-531
11-digit product format
649800531
Labeler code
64980
Product ID
64980-531_92fdb885-c818-4c39-909a-7f2f53840d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
RISING PHARMA HOLDINGS, INC.
Application
ANDA209025
Marketing category
ANDA
Marketing start
2023-04-01
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
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
64980-531-0164980053101100 TABLET in 1 BOTTLE (64980-531-01) 100 tablet2023-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYBUTYNIN CHLORIDE TABLETS, USPRISING PHARMA HOLDINGS, INC. | Appco Pharma LLC2024-07-03Human Prescription Drug Label8