NDC 31722-359-30
API & Excipient Details

Phentermine Hydrochloride marketed by Camber Pharmaceuticals, Inc. under NDC Code 31722-359-30

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)	PHENTERMINE HYDROCHLORIDE	37.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31722-359-30	30 in 1 BOTTLE
2	NDC:31722-359-01	100 in 1 BOTTLE
3	NDC:31722-359-10	1000 in 1 BOTTLE

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