NDC Code(s) : 0904-6665-61, 0904-6667-61, 0904-6666-61
Packager : Major Pharmaceuticals

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:0904-6665(NDC:67877-222)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
TALC(UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White) Score no score
Shape CAPSULE (Capsule) Size 14 mm
Flavor Imprint Code 216
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6665-61100 in 1 CARTON 29/01/2011
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090858 01/29/2011
GabapentinGabapentin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6667(NDC:67877-224)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN(UNII: 6CW7F3G59X)
(GABAPENTIN - UNII:6CW7F3G59X) 		GABAPENTIN400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
TALC(UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color ORANGE (orange) Score no score
Shape CAPSULE (Capsule) Size 21 mm
Flavor Imprint Code 214
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6667-61100 in 1 CARTON 29/01/2011
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090858 01/29/2011
GabapentinGabapentin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6666(NDC:67877-223)
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)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
TALC(UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (yellow) Score no score
Shape CAPSULE (Capsule) Size 19 mm
Flavor Imprint Code 215
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6666-61100 in 1 CARTON 29/01/2011
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090858 01/29/2011

LABELER - Major Pharmaceuticals(191427277)

PRINCIPAL DISPLAY PANEL

Gabapentin Capsules, USP

100 mg

100 Capsules

Carton label

PRINCIPAL DISPLAY PANEL

Gabapentin Capsules, USP

300 mg

100 Capsules

Carton label

PRINCIPAL DISPLAY PANEL

Gabapentin Capsules, USP

400 mg

100 Capsules

carton label