NDC Code 16477-505-01 - Prednisolone

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PREDNISOLONE(UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)	PREDNISOLONE	5 mg in 5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:16477-505-01	5 mg in 1 BOTTLE Type 0: Not a Combination Product	01/10/2008
2	NDC:16477-505-21	5 mg in 1 BLISTER PACK Type 0: Not a Combination Product	01/10/2008
3	NDC:16477-505-48	5 mg in 1 BLISTER PACK Type 0: Not a Combination Product	01/10/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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