NDC Code(s) : 49884-257-01, 49884-257-05, 49884-256-01
Packager : Par Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MinoxidilMinoxidil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-257
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOXIDIL(UNII: 5965120SH1)
(MINOXIDIL - UNII:5965120SH1) 		MINOXIDIL10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code Par257;Minoxidil10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-257-01100 in 1 BOTTLE Type 0: Not a Combination Product14/11/1988
2NDC:49884-257-05500 in 1 BOTTLE Type 0: Not a Combination Product14/11/1988
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071839 11/14/1988
MinoxidilMinoxidil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-256
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOXIDIL(UNII: 5965120SH1)
(MINOXIDIL - UNII:5965120SH1) 		MINOXIDIL2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code Par256;Minoxidil;2;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-256-01100 in 1 BOTTLE Type 0: Not a Combination Product14/11/1988
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071826 11/14/1988

LABELER - Par Pharmaceutical, Inc.(092733690)

PRINCIPAL DISPLAY PANEL

2.5 mg label

PRINCIPAL DISPLAY PANEL

10 mg label