NDC Code(s) : 52125-866-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SpironolactoneSpironolactone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-866(NDC:53746-511)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE(UNII: 27O7W4T232)
(SPIRONOLACTONE - UNII:27O7W4T232) 		SPIRONOLACTONE25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
STARCH, CORN(UNII: O8232NY3SJ)
PEPPERMINT(UNII: V95R5KMY2B)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONES(UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYDEXTROSE(UNII: VH2XOU12IE)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
Product Characteristics
Color white Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code AN;511
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-866-0230 in 1 BLISTER PACK Type 0: Not a Combination Product11/03/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091426 03/11/2014 03/28/2017

PRINCIPAL DISPLAY PANEL

DRUG: Spironolactone

GENERIC: Spironolactone

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-866-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: AN;511

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • SPIRONOLACTONE 25mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM SULFATE DIHYDRATE
  • POLYDEXTROSE
  • TITANIUM DIOXIDE
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • TRIACETIN
  • CELLULOSE, MICROCRYSTALLINE
  • PEPPERMINT
  • STARCH, CORN
  • CROSCARMELLOSE SODIUM
  • POLYETHYLENE GLYCOL 8000
  • POVIDONES

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