Spironolactone tablet, film coated

Ingredients and appearance - Product information

Spironolactone tablet, film coated- Spironolactone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43063-802
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Spironolactone ( UNII: 27O7W4T232)( Spironolactone - UNII: 27O7W4T232 ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium sulfate ( UNII: WAT0DDB505)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidone ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color white Imprint Code 58;82;V
Score 2 Shape ROUND
Size 12 mm


# Item Code Package Description Marketing Start Date
1 NDC: 43063-802-30 30 in 1 BOTTLE, PLASTIC 2017/11/02
2 NDC: 43063-802-90 90 in 1 BOTTLE, PLASTIC 2017/11/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040750 USA 2017/11/02

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)


Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 43063-802)