NDC 63629-7309-1
API & Excipient Details

Gabapentin marketed by Bryant Ranch Prepack under NDC Code 63629-7309-1

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-7309-1	90 in 1 BOTTLE Type 0: Not a Combination Product	14/07/2017
2	NDC:63629-7309-2	28 in 1 BOTTLE Type 0: Not a Combination Product	21/02/2022
3	NDC:63629-7309-3	120 in 1 BOTTLE Type 0: Not a Combination Product	10/04/2018
4	NDC:63629-7309-4	30 in 1 BOTTLE Type 0: Not a Combination Product	20/11/2019
5	NDC:63629-7309-5	60 in 1 BOTTLE Type 0: Not a Combination Product	23/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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