Oxybutynin chloride tablet

Ingredients and appearance - Product information

Oxybutynin chloride tablet- Oxybutynin chloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50436-4777
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxybutynin chloride ( UNII: L9F3D9RENQ)( Oxybutynin - UNII: K9P6MC7092 ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium stearate ( UNII: 776XM7047L)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Aluminum oxide ( UNII: LMI26O6933)

Product Characteristics

Color BLUE (very pale blue) Imprint Code PLIVA;456
Score 2 Shape ROUND
Size 8 mm


# Item Code Package Description Marketing Start Date
1 NDC: 50436-4777-1 30 in 1 BOTTLE 1990/09/30
2 NDC: 50436-4777-2 60 in 1 BOTTLE 1990/09/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA071655 USA 1990/09/30

Labeler - Unit Dose Services( 831995316)


Name ID/FEI Business Operations
Unit Dose Services 831995316 REPACK( 50436-4777), RELABEL( 50436-4777)

Oxybutynin chloride tablet

Reflects Cmax for pooled data
AUC0-end of dosing interval