NDC Code(s) : 63629-9589-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NEBIVOLOLnebivolol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-9589(NDC:43547-525)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEBIVOLOL(UNII: 030Y90569U)
(NEBIVOLOL - UNII:030Y90569U) 		NEBIVOLOL5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFOACETATE(UNII: D0Y70F2B9J)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color YELLOW Score no score
Shape TRIANGLE Size 10 mm
Flavor Imprint Code 672;s
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-9589-190 in 1 BOTTLE Type 0: Not a Combination Product12/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212682 02/14/2022

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-9589), RELABEL(63629-9589)

PRINCIPAL DISPLAY PANEL

Nebivolol 5mg Tablets

Label