Home NDC 0456-1420 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021742-002 BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 N021742-003 BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 N021742-004 BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 N021742-005 BYSTOLIC NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021742-002 BYSTOLIC EQ 2.5MG BASE TABLET / ORAL AB RLD 2007-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021742-003 BYSTOLIC EQ 5MG BASE TABLET / ORAL AB RLD 2007-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021742-004 BYSTOLIC EQ 10MG BASE TABLET / ORAL AB RLD 2007-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021742-005 BYSTOLIC EQ 20MG BASE TABLET / ORAL AB RLD, RS 2008-10-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book patent history# Additional Listing Data#
Finished product Yes
Brand name base Bystolic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEBIVOLOL HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JGS34J7L9I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 387013 Internal RxNorm lookup 751612 Internal RxNorm lookup 751616 Internal RxNorm lookup 751618 Internal RxNorm lookup 751620 Internal RxNorm lookup 751623 Internal RxNorm lookup 827073 Internal RxNorm lookup 827075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0456-1420-01 Bystolic 100 in 1 BOTTLE TABLET 100 31 0456-1420-30 Bystolic 30 in 1 BOTTLE TABLET 30 31 0456-1420-63 Bystolic 100 in 1 BOX, UNIT-DOSE TABLET 100 31 0456-1420-90 Bystolic 90 in 1 BOTTLE TABLET 90 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded nebivolol hydrochloride ACTIVE INGREDIENT JGS34J7L9I BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 nebivolol ACTIVE MOIETY 030Y90569U BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 starch, corn INACTIVE INGREDIENT O8232NY3SJ BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] 12 NEBIVOLOL HYDROCHLORIDE ACTIVE INGREDIENT JGS34J7L9I BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 NEBIVOLOL ACTIVE MOIETY 030Y90569U BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9 starch, corn INACTIVE INGREDIENT O8232NY3SJ BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0456-1420 BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [ALLERGAN, INC.] 30 Current NDC, Legacy NDC, 4 package rows 20241105_8b8ad213-1dc8-454e-a524-075685c0e1a8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0456-1420-01 00456142001 100 TABLET in 1 BOTTLE (0456-1420-01) 100 tablet 2008-01-22 0000-00-00 No No Current 0456-1420-30 00456142030 30 TABLET in 1 BOTTLE (0456-1420-30) 30 tablet 2008-01-22 2023-11-30 No No Current 0456-1420-63 00456142063 100 TABLET in 1 BOX, UNIT-DOSE (0456-1420-63) 100 tablet 2008-01-22 0000-00-00 No No Current 0456-1420-90 00456142090 90 TABLET in 1 BOTTLE (0456-1420-90) 90 tablet 2008-01-22 0000-00-00 No No Current