Gabapentin (Page 10 of 10)

PRINCIPAL DISPLAY PANEL


NDC 59063-127-47

GabapentinOral Solution

250 mg/5 mL

PHARMACIST: Please dispense Medication Guide provided separately.

Rx Only

470 mL

KIEL LABORATORIES®


gabapentin-06
(click image for full-size original)
GABAPENTIN gabapentin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59063-127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROCHLORIC ACID
WATER
SODIUM HYDROXIDE
XYLITOL
Product Characteristics
Color Score
Shape Size
Flavor ANISE (ANISE) , STRAWBERRY (STRAWBERRY) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59063-127-47 470 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076403 05/01/2012
Labeler — Kiel Laboratories, Inc. (015686298)
Establishment
Name Address ID/FEI Operations
C.P.M. ContractPharma GmbH & Co. KG Arzneimittelherstellung 315113691 manufacture

Revised: 04/2012 Kiel Laboratories, Inc.

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