NDC Code(s) : 64850-810-01, 64850-810-10
Packager : Elite Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Phentermine Hydrochloride Phentermine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64850-810
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
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (Blue Specs) Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code 810
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64850-810-01100 in 1 BOTTLE Type 0: Not a Combination Product05/01/2014
2NDC:64850-810-101000 in 1 BOTTLE Type 0: Not a Combination Product05/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040190 05/01/2014

LABELER - Elite Laboratories, Inc.(785398728)

REGISTRANT - Elite Laboratories, Inc.(785398728)

Establishment
Name Address ID/FEI Business Operations
Elite Laboratories, Inc. 785398728 LABEL(64850-810), MANUFACTURE(64850-810)

PRINCIPAL DISPLAY PANEL

NDC 64850-810-01
CIV
Phentermine HCl Tablets, USP 37.5 mg
Elite
100 TABLETS
Rx only





NDC 64850-810-10
CIV
Phentermine HCl Tablets, USP 37.5 mg
Elite
1000 TABLETS
Rx only