GABAPENTIN- gabapentin capsule 
Aphena Pharma Solutions - Tennessee, LLC

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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

gab medguide

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:

Count400 mg
9071610-195-60
27071610-195-92

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:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20190801JH

PRINCIPAL DISPLAY PANEL - 400 mg

NDC 71610-195 - Gabapentin, USP 400 mg - Rx Only
Bottle Label 400 mg

GABAPENTIN 
gabapentin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71610-195(NDC:49483-607)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN400 mg
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code 105
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-195-6090 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2018
2NDC:71610-195-92270 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09000712/30/2015
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-195)

Revised: 8/2019
Document Id: 5918274e-e48f-4599-83dc-e782c98847f9
Set id: b552a38a-5ada-4e79-a5ed-c785dcf5b568
Version: 3
Effective Time: 20190801
 
Aphena Pharma Solutions - Tennessee, LLC