GABAPENTIN

GABAPENTIN- gabapentin capsule
Direct_Rx


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
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
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

640-90
(click image for full-size original)

GABAPENTIN
gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-640(NDC:49483-606)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
TALC
GELATIN
STARCH, CORN
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-640-90 90 CAPSULE in 1 BOTTLE None
2 NDC:61919-640-82 180 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 08/19/2019
Labeler — Direct_Rx (079254320)
Registrant — Direct_Rx (079254320)
Establishment
Name Address ID/FEI Operations
Direct_Rx 079254320 repack (61919-640)

Revised: 04/2021 Direct_Rx

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