NDC Code(s) : 16477-505-01, 16477-505-21, 16477-505-48
Packager : Laser Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MILLIPREDPREDNISOLONE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16477-505
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE(UNII: 9PHQ9Y1OLM)
(PREDNISOLONE - UNII:9PHQ9Y1OLM) 		PREDNISOLONE5 mg in 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Product Characteristics
Color orange (PEACH) Score 2 pieces
Shape ROUND (TABLET) Size 6 mm
Flavor Imprint Code DANDAN5059
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16477-505-015 mg in 1 BOTTLE Type 0: Not a Combination Product01/10/2008
2NDC:16477-505-215 mg in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2008
3NDC:16477-505-485 mg in 1 BLISTER PACK Type 0: Not a Combination Product01/10/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080354 10/01/2008 07/03/2017

PRINCIPAL DISPLAY PANEL

MANUFACTURED BY: WATSON PHARMA PRIVATE LIMITED VERNA, SALCETTE Goa 403 722 INDIA

DISTRIBUTED BY: LASER PHARMACEUTICALS, LLC GREENVILLE, SC 29615

REVISED : 8/2011   0811A  173415


MILLIPRED LABEL


MILLIPRED LABEL


MILLIPRED LABEL


MILLIPRED LABEL

MILLIPRED LABEL