NDC Code(s) : 42806-524-01, 42806-524-10
Packager : Epic Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-524
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE(UNII: 0K2I505OTV)
(PHENTERMINE - UNII:C045TQL4WP) 		PHENTERMINE37.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
METHYL ALCOHOL(UNII: Y4S76JWI15)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color BLUE (Bright Blue Opaque Cap, White Opaque Body) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code E524
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-524-01100 in 1 BOTTLE Type 0: Not a Combination Product15/04/2015
2NDC:42806-524-101000 in 1 BOTTLE Type 0: Not a Combination Product15/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040228 04/15/2015

LABELER - Epic Pharma, LLC(827915443)

REGISTRANT - Epic Pharma, LLC(827915443)

Establishment
Name Address ID/FEI Business Operations
Epic Pharma, LLC 827915443 MANUFACTURE(42806-524)

PRINCIPAL DISPLAY PANEL

Phentermine Hydrochloride Capsules USP

37.5 mg 100 Capsules

CIV

Rx Only

100ct label

PRINCIPAL DISPLAY PANEL

Phentermine Hydrochloride Capsules USP

37.5 mg 1000 Capsules

CIV

Rx Only

1000ct label