GABAPENTIN by St. Mary’s Medical Park Pharmacy GABAPENTIN capsule

GABAPENTIN by

Drug Labeling and Warnings

GABAPENTIN by is a Prescription medication manufactured, distributed, or labeled by St. Mary’s Medical Park Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder)

NDC: 60760-0605-60 BOTTLE OF 60

60760-0605-90 BOTTLE OF 90

60760-0605-30 BOTTLE OF 30

MEDICATION GUIDE

100 mg Gabapentin Capsule Package Labels

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60760-605(NDC:49483-605)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	100 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	103
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60760-605-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/26/2017
2	NDC: 60760-605-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/29/2017
3	NDC: 60760-605-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090007	12/26/2017

Labeler - St. Mary’s Medical Park Pharmacy (063050751)

Establishment
Name	Address	ID/FEI	Business Operations
St. Mary’s Medical Park Pharmacy		063050751	repack(60760-605) , relabel(60760-605)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(60760-605)