NDC Code(s) : 31722-359-30, 31722-359-01, 31722-359-10
Packager : Camber Pharmaceuticals, Inc.

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: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)
COLLOIDAL SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAIZE INVERT SUGAR(UNII: ED959S6ACY)
MAGNESIUM STEARATE(UNII: 70097M6I30)
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:31722-359-3030 in 1 BOTTLE
2NDC:31722-359-01100 in 1 BOTTLE
3NDC:31722-359-101000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202942 04/02/2014

LABELER - Camber Pharmaceuticals, Inc.(826774775)

Establishment
Name Address ID/FEI Business Operations
InvaGen Pharmaceuticals, Inc. 165104469 manufacture(31722-359)

PRINCIPAL DISPLAY PANEL

Phentermine Hydrochloride 37.5 mg- 30 Tablets

30ct