NDC Code(s) : 0025-1001-31, 0025-1041-31, 0025-1031-31
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aldactonespironolactone TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1001
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
STARCH, CORN(UNII: O8232NY3SJ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
PEPPERMINT(UNII: V95R5KMY2B)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
CARNAUBA WAX(UNII: R12CBM0EIZ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code SEARLE;1001;ALDACTONE;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1001-31100 in 1 BOTTLE Type 0: Not a Combination Product21/01/1960
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012151 01/21/1960
Aldactonespironolactone TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE(UNII: 27O7W4T232)
(SPIRONOLACTONE - UNII:27O7W4T232) 		SPIRONOLACTONE50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
PEPPERMINT(UNII: V95R5KMY2B)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
CARNAUBA WAX(UNII: R12CBM0EIZ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color ORANGE (light orange) Score 2 pieces
Shape OVAL Size 14 mm
Flavor Imprint Code SEARLE;1041;ALDACTONE;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1041-31100 in 1 BOTTLE Type 0: Not a Combination Product21/01/1960
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012151 01/21/1960
Aldactonespironolactone TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0025-1031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE(UNII: 27O7W4T232)
(SPIRONOLACTONE - UNII:27O7W4T232) 		SPIRONOLACTONE100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
PEPPERMINT(UNII: V95R5KMY2B)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
CARNAUBA WAX(UNII: R12CBM0EIZ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code SEARLE;1031;ALDACTONE;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0025-1031-31100 in 1 BOTTLE Type 0: Not a Combination Product21/01/1960
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012151 01/21/1960

LABELER - Pfizer Laboratories Div Pfizer Inc(134489525)

REGISTRANT - Pfizer Inc(113480771)

Establishment
Name Address ID/FEI Business Operations
Pfizer Inc 943955690 ANALYSIS(0025-1001, 0025-1041, 0025-1031)

PRINCIPAL DISPLAY PANEL

Pfizer

NDC 0025-1001-31

Aldactone®
(spironolactone)
tablets, USP

25 mg

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

Pfizer

NDC 0025-1041-31

Aldactone®
(spironolactone)
tablets, USP

50 mg

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

Pfizer

NDC 0025-1031-31

Aldactone®
(spironolactone)
tablets, USP

100 mg

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label