NDC Code(s) : 43063-665-10, 43063-665-30, 43063-665-60, 43063-665-90
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GabapentinGabapentin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-665(NDC:16714-662)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 20 mm
Flavor Imprint Code D;03
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-665-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/01/2008
2NDC:43063-665-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/01/2008
3NDC:43063-665-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/01/2008
4NDC:43063-665-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/01/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008

PRINCIPAL DISPLAY PANEL

Rx only
Gabapentin Capsules, USP
300 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.


43063665 LABEL