GABAPENTIN by RPK Pharmaceuticals, Inc. GABAPENTIN capsule

GABAPENTIN by

Drug Labeling and Warnings

GABAPENTIN by is a Prescription medication manufactured, distributed, or labeled by RPK Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

Product: 53002-2423

NDC: 53002-2423-3 30 CAPSULE in a BOTTLE

NDC: 53002-2423-6 60 CAPSULE in a BOTTLE

NDC: 53002-2423-0 100 CAPSULE in a BOTTLE

MEDICATION GUIDE

Gabapentin 300mg Capsules

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53002-2423(NDC:49483-606)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	300 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53002-2423-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 53002-2423-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
3	NDC: 53002-2423-0	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090007	12/30/2015

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Establishment
Name	Address	ID/FEI	Business Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-2423) , REPACK(53002-2423)