NDC Code(s) : 54288-129-10, 54288-130-09
Packager : BPI Labs LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FENORTHOFENORTHO CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54288-129
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOPROFEN CALCIUM(UNII: 0X2CW1QABJ)
(FENOPROFEN - UNII:RA33EAC7KY) 		FENOPROFEN200 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
Product Characteristics
Color yellow (opaque), white (opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code RX681
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54288-129-10100 in 1 BOTTLE Type 1: Convenience Kit of Co-Package14/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017604 06/14/2016 03/21/2017
FENORTHOFENORTHO CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54288-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOPROFEN CALCIUM(UNII: 0X2CW1QABJ)
(FENOPROFEN - UNII:RA33EAC7KY) 		FENOPROFEN400 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color green, blue Score no score
Shape capsule Size 23 mm
Flavor Imprint Code NAFLON400mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54288-130-0990 in 1 BOTTLE Type 1: Convenience Kit of Co-Package14/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017604 06/14/2016 03/21/2017

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 200 mg
NDC 54288-129-10

Fenortho capsules

200 mg

200mgimg

Manufactured for:
BPI Labs, LLC
Freehold, NJ 07728

100 capsules

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 400 mg
NDC 54288-130-09
Fenortho capsules
400 mg

400mgimage

Manufactured for:
BPI Labs, LLC
Freehold, NJ 07728

90 capsules