MedPath
FDA Product

Oxybutynin Chloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Oxybutynin Chloride

50090-4728

Regulatory Information

50090-4728

ANDA204010

C73584

April 23, 2021

USA

These highlights do not include all the information needed to use OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS. OXYBUTYNIN CHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1975

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

830016429

Active Ingredients

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Code: NX76LV5T8J

Class Code: IACT

OXYBUTYNIN CHLORIDE

Quantity: 5 mg in 1 1

Code: L9F3D9RENQ

Class Code: ACTIB

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

HYDROGENATED COTTONSEED OIL

Code: Z82Y2C65EA

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

D&C RED NO. 27

Code: 2LRS185U6K

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

OXYBUTYNIN

Code: K9P6MC7092

© Copyright 2025. All Rights Reserved by MedPath