NDC Code(s) : 60760-987-90
Packager : ST. MARY'S MEDICAL PARK PHARMACY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GABAPENTINGabapentin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-987(NDC:31722-166)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN600 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
CROSPOVIDONE(UNII: 2S7830E561)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code T;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60760-987-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214957 10/01/2021

LABELER - ST. MARY'S MEDICAL PARK PHARMACY(063050751)

Establishment
Name Address ID/FEI Business Operations
ST. MARY'S MEDICAL PARK PHARMACY 063050751 relabel(60760-987), repack(60760-987)

PRINCIPAL DISPLAY PANEL

987-90