Gabapentin (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 600 mg Bottle Label

Gabapentin Tablets 600 mg 60's
(click image for full-size original)

Gabapentin Tablets 600 mg 60’s

GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-122(NDC:71093-111)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 407
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (white to off -White) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code NT;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-122-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:45865-122-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:45865-122-90 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:45865-122-51 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203244 01/11/2014
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-122)

Revised: 10/2020 Medsource Pharmaceuticals

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