NDC Code(s) : 63629-7309-1, 63629-7309-2, 63629-7309-3, 63629-7309-4, 63629-7309-5
Packager : Bryant Ranch Prepack

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:63629-7309(NDC:45963-557)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MANNITOL(UNII: 3OWL53L36A)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
Product Characteristics
Color ORANGE, BROWN (LIGHT) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 667;667
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-7309-190 in 1 BOTTLE Type 0: Not a Combination Product14/07/2017
2NDC:63629-7309-228 in 1 BOTTLE Type 0: Not a Combination Product21/02/2022
3NDC:63629-7309-3120 in 1 BOTTLE Type 0: Not a Combination Product10/04/2018
4NDC:63629-7309-430 in 1 BOTTLE Type 0: Not a Combination Product20/11/2019
5NDC:63629-7309-560 in 1 BOTTLE Type 0: Not a Combination Product23/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075350 04/03/2014

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-7309), RELABEL(63629-7309)

PRINCIPAL DISPLAY PANEL

Gabapentin 400mg (CV) Capsule

Label