NDC Code(s) : 52682-500-01
Packager : Ingenus Pharmaceuticals NJ, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDE CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52682-500
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEVIMELINE HYDROCHLORIDE(UNII: P81Q6V85NP)
(CEVIMELINE - UNII:K9V0CDQ56E) 		CEVIMELINE30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (Opaque white cap and body) Score no score
Shape CAPSULE (CAPSULE) Size 16 mm
Flavor Imprint Code P;657
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52682-500-01100 in 1 BOTTLE Type 0: Not a Combination Product17/06/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203775 06/17/2014

PRINCIPAL DISPLAY PANEL

NDC 52682-500-01
Cevimeline
Hydrochloride
Capsules

30 mg
PHARMACIST: PLEASE DISPENSE WITH ATTACHED
PATIENT INFORMATION LEAFLET
100 Capsules
Ingenus Pharmaceuticals NJ, LLC
Rx only

Cevimeline Hydrochloride Capsules 30 mg