Gabapentin (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 470 mL Bottle Label

NDC 51991-714-16

Gabapentin
Oral Solution

250 mg per 5 mL

Rx Only

PHARMACIST: Dispense the
Medication Guide provided
separately to each patient.

16 fl. oz. (470 mL)

Breckenridge Pharmaceutical, Inc.

PRINCIPAL DISPLAY PANEL -- 470 mL Bottle Label
(click image for full-size original)
GABAPENTIN gabapentin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-714
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
MALTITOL
METHYLPARABEN
PROPYLPARABEN
WATER
Product Characteristics
Color YELLOW (clear colorless to pale yellow) Score
Shape Size
Flavor ANISE, STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-714-16 470 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091286 05/01/2017
Labeler — Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Tris Pharma, Inc. 947472119 MANUFACTURE (51991-714), ANALYSIS (51991-714)

Revised: 03/2016 Breckenridge Pharmaceutical, Inc.

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