NDC Code(s) : 72162-2121-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

POTASSIUM CITRATEPotassium Citrate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72162-2121(NDC:31722-132)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CITRATE(UNII: EE90ONI6FF)
(ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) 		POTASSIUM CITRATE15 meq
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code T;401
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72162-2121-1100 in 1 BOTTLE Type 0: Not a Combination Product18/09/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214420 02/15/2021

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(72162-2121), RELABEL(72162-2121)

PRINCIPAL DISPLAY PANEL

Potassium Citrate15 mEq Tab #100

Label