GABAPENTIN by Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN capsule

GABAPENTIN by

Drug Labeling and Warnings

GABAPENTIN by is a Prescription medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. 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) Bottles of 100 & 500

HOW SUPPLIED

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

HOW SUPPLIED

400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

MEDICATION GUIDE

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 400 mg
• 90: 71610-195-60
• 270: 71610-195-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190801JH

PRINCIPAL DISPLAY PANEL - 400 mg

NDC: 71610-195 - Gabapentin, USP 400 mg - Rx Only

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71610-195(NDC:49483-607)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	105
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-195-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2018
2	NDC: 71610-195-92	270 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2018

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

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-195)