Gaba 300-EZS (Page 8 of 8)

PharmapureRx® Pill Swallowing Spray™

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Gaba 300-EZS

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Established Pharmacological Class
Substance Pharmacological Class
PharmapureRx Pill Swallowing Spray Moisturizing
GABA 300-EZS gabapentin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-725
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-725-00 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 100
Part 2 1 BOTTLE, SPRAY 59 mL
Part 1 of 2
GABAPENTIN gabapentin capsule
Product Information
Item Code (Source) NDC:45963-556
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MANNITOL
PROPYLENE GLYCOL
FERRIC OXIDE RED
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SHELLAC
ALUMINUM HYDROXIDE
Product Characteristics
Color yellow, brown (LIGHT) Score no score
Shape capsule Size 19mm
Flavor Imprint Code 2666
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-556-11 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075350
Part 2 of 2
PHARMAPURERX PILL SWALLOWING SPRAY
Product Information
Item Code (Source) GS1:7-31477-27221-7
Packaging
# Item Code Package Description Multilevel Packaging
1 GS1:7-31477-27221-7 59 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075350 10/22/2018
Labeler — PureTek Corporation (785961046)

Revised: 10/2018 PureTek Corporation

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