NDC Code(s) : 0904-6927-61
Packager : Major Pharmaceuticals

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:0904-6927(NDC:68382-660)
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)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 7 mm
Flavor PEPPERMINT Imprint Code 660
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6927-61100 in 1 CARTON 15/08/2018
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205936 08/15/2018

LABELER - Major Pharmaceuticals(191427277)

PRINCIPAL DISPLAY PANEL

Spironolactone Tablets, USP

25 mg

100 Tablets

Carton label