FDA.reportPublic FDA data

Bystolic

Product NDC
0456-1420
11-digit product format
004561420
Labeler code
0456
Product ID
0456-1420_0096cdf0-43e6-4128-8990-aed7e1fab83f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA021742
Marketing category
NDA
Marketing start
2008-01-22
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bystolic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui387013, 751612, 751616, 751618, 751620, 751623, 827073, 827075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b9af42fa-00cc-b314-02ce-e06da0a12313Product name620250423
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-1420-01Bystolic100 in 1 BOTTLETABLET10031
0456-1420-30Bystolic30 in 1 BOTTLETABLET3031
0456-1420-63Bystolic100 in 1 BOX, UNIT-DOSETABLET10031
0456-1420-90Bystolic90 in 1 BOTTLETABLET9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-1420-01EA - Each0456-14202aa498da-6809-47d7-a56e-7104f9acc69712012-07-24
0456-1420-30EA - Each0456-1420e641fb68-3837-47f0-9f44-ab2f5a1b377d12012-07-24
0456-1420-90EA - Each0456-1420d0773787-2463-47db-a2c2-c2d9cff1ac6212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nebivolol hydrochlorideACTIVE INGREDIENTJGS34J7L9IBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
nebivololACTIVE MOIETY030Y90569UBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
magnesium stearateINACTIVE INGREDIENT70097M6I30BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12
starch, cornINACTIVE INGREDIENTO8232NY3SJBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-1420BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [ALLERGAN, INC.]30Current NDC, Legacy NDC, 4 package rows20241105_8b8ad213-1dc8-454e-a524-075685c0e1a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751616Bystolic 10 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
751620Bystolic 2.5 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
827075Bystolic 20 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
751623Bystolic 5 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
751612nebivolol 10 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
751618nebivolol 2.5 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
827073nebivolol 20 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
387013nebivolol 5 MG Oral TabletPSN8b8ad213-1dc8-454e-a524-075685c0e1a831
751616nebivolol 10 MG Oral Tablet [Bystolic]SBD8b8ad213-1dc8-454e-a524-075685c0e1a831
751620nebivolol 2.5 MG Oral Tablet [Bystolic]SBD8b8ad213-1dc8-454e-a524-075685c0e1a831
827075nebivolol 20 MG Oral Tablet [Bystolic]SBD8b8ad213-1dc8-454e-a524-075685c0e1a831
751623nebivolol 5 MG Oral Tablet [Bystolic]SBD8b8ad213-1dc8-454e-a524-075685c0e1a831
751612nebivolol 10 MG Oral TabletSCD8b8ad213-1dc8-454e-a524-075685c0e1a831
751618nebivolol 2.5 MG Oral TabletSCD8b8ad213-1dc8-454e-a524-075685c0e1a831
827073nebivolol 20 MG Oral TabletSCD8b8ad213-1dc8-454e-a524-075685c0e1a831
387013nebivolol 5 MG Oral TabletSCD8b8ad213-1dc8-454e-a524-075685c0e1a831
751616Bystolic (as nebivolol HCl) 10 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751620Bystolic (as nebivolol HCl) 2.5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
827075Bystolic (as nebivolol HCl) 20 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751623Bystolic (as nebivolol HCl) 5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751616Bystolic 10 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751620Bystolic 2.5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
827075Bystolic 20 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751623Bystolic 5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY8b8ad213-1dc8-454e-a524-075685c0e1a831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-1420-0100456142001100 TABLET in 1 BOTTLE (0456-1420-01) 100 tablet2008-01-220000-00-00NoNoCurrent
0456-1420-300045614203030 TABLET in 1 BOTTLE (0456-1420-30) 30 tablet2008-01-222023-11-30NoNoCurrent
0456-1420-6300456142063100 TABLET in 1 BOX, UNIT-DOSE (0456-1420-63) 100 tablet2008-01-220000-00-00NoNoCurrent
0456-1420-900045614209090 TABLET in 1 BOTTLE (0456-1420-90) 90 tablet2008-01-220000-00-00NoNoCurrent