Gabapentin (Page 8 of 8)

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GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-815(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:55700-815-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55700-815-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55700-815-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203244 11/08/2019
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 repack (55700-815)

Revised: 08/2020 Quality Care Products, LLC

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