GABAPENTIN (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Gabapentin
Tablets, USP
800 mg Rx Only

image
(click image for full-size original)
GABAPENTIN gabapentin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-756(NDC:58657-624)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 800 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
TALC
COPOVIDONE
CROSPOVIDONE
SILICON DIOXIDE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLOXAMER 407
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape CAPSULE (modified capsule shape) Size 19mm
Flavor Imprint Code SG;178
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-756-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-756-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-756-83 540 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:43063-756-86 360 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:43063-756-90 90 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:43063-756-93 180 TABLET in 1 BOTTLE, PLASTIC None
7 NDC:43063-756-94 270 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205101 11/20/2016
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-756)

Revised: 03/2020 PD-Rx Pharmaceuticals, Inc.

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