NDC Code(s) : 68645-485-54
Packager : Legacy Pharmaceutical Packaging, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Phentermine HydrochloridePhentermine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-485(NDC:31722-359)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV)
(PHENTERMINE - UNII:C045TQL4WP) 		PHENTERMINE HYDROCHLORIDE37.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MAIZE INVERT SUGAR(UNII: ED959S6ACY)
Product Characteristics
Color WHITE (white with blue specks) Score 2 pieces
Shape CAPSULE (modified capsule shaped, biconvex tablets) Size 4 mm
Flavor Imprint Code I;G;359
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-485-5430 in 1 BOTTLE Type 0: Not a Combination Product02/04/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202942 04/02/2014 05/31/2016

PRINCIPAL DISPLAY PANEL

Phentermine Hydrochloride Tablets, USP 37.5mg