Bystolic (Page 6 of 6)

BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET

Label ImageLabel Image
BYSTOLIC
nebivolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5135(NDC:0456-1410)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nebivolol hydrochloride (nebivolol) nebivolol 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POLYSORBATE 80
SODIUM LAURYL SULFATE
Product Characteristics
Color purple (purple) Score no score
Shape TRIANGLE (TRIANGLE) Size 10mm
Flavor Imprint Code 10;FL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-5135-7 1 TABLET in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021742 01/22/2008
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-5135)

Revised: 01/2014 Carilion Materials Management

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