NDC Code(s) : 49884-269-52, 49884-269-11, 49884-268-52, 49884-268-11
Packager : Par Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-269
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE40 mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20) 		SODIUM BICARBONATE1680 mg
Inactive Ingredients
Ingredient Name Strength
XYLITOL(UNII: VCQ006KQ1E)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCRALOSE(UNII: 96K6UQ3ZD4)
PEACH(UNII: 3OKE88I3QG)
SUCROSE(UNII: C151H8M554)
PEPPERMINT(UNII: V95R5KMY2B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-269-1130 in 1 CARTON 18/07/2016
1NDC:49884-269-521 in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079182 07/18/2016
Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-268
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE20 mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20) 		SODIUM BICARBONATE1680 mg
Inactive Ingredients
Ingredient Name Strength
XYLITOL(UNII: VCQ006KQ1E)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCRALOSE(UNII: 96K6UQ3ZD4)
PEACH(UNII: 3OKE88I3QG)
SUCROSE(UNII: C151H8M554)
PEPPERMINT(UNII: V95R5KMY2B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-268-1130 in 1 CARTON 18/07/2016
1NDC:49884-268-521 in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079182 07/18/2016

LABELER - Par Pharmaceutical, Inc.(092733690)

REGISTRANT - Par Pharmaceutical Inc.(092733690)

PRINCIPAL DISPLAY PANEL

20 mg Pouch

PRINCIPAL DISPLAY PANEL

40 mg Pouch