Bystolic

Product NDC
55154-4621
Requested package NDC
55154-4621-2
11-digit product format
551544621
Labeler code
55154
Product ID
55154-4621_c37198df-721d-4fb1-824e-17dc3d29dbe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Application
NDA021742
Marketing category
NDA
Marketing start
2008-01-22
Marketing end
2023-06-30
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55154-462155154-4621-2DDiscontinued by firm2026-08-11

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021742-002BYSTOLICNEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALABRLD2007-12-17
N021742-003BYSTOLICNEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALABRLD2007-12-17
N021742-004BYSTOLICNEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRLD2007-12-17
N021742-005BYSTOLICNEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021742-002AB
N021742-003AB
N021742-004AB
N021742-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021742-002BYSTOLICEQ 2.5MG BASETABLET / ORALABRLD2007-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-003BYSTOLICEQ 5MG BASETABLET / ORALABRLD2007-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-004BYSTOLICEQ 10MG BASETABLET / ORALABRLD2007-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-005BYSTOLICEQ 20MG BASETABLET / ORALABRLD, RS2008-10-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021742-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021742-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021742-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021742-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021742-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021742-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021742-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021742-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021742-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021742-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021742-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021742-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021742-005AB1d06236e962d9…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021742-00265450402021-12-17U-3Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021742-00365450402021-12-17U-3Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021742-00465450402021-12-17U-3Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021742-00565450402021-12-17U-3Drug product74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021742-00265450402021-12-17U-3Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021742-00365450402021-12-17U-3Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021742-00465450402021-12-17U-3Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021742-00565450402021-12-17U-3Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021742-00265450402021-12-17U-3Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021742-00365450402021-12-17U-3Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021742-00465450402021-12-17U-3Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021742-00565450402021-12-17U-3Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021742-00265450402021-12-17U-3Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021742-00365450402021-12-17U-3Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021742-00465450402021-12-17U-3Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021742-00565450402021-12-17U-3Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021742-00265450402021-12-17U-3Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021742-00365450402021-12-17U-3Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021742-00465450402021-12-17U-3Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021742-00565450402021-12-17U-3Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021742-00265450402021-12-17U-3Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021742-00365450402021-12-17U-3Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021742-00465450402021-12-17U-3Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021742-00565450402021-12-17U-3Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021742-00265450402021-12-17U-3Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021742-00365450402021-12-17U-3Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021742-00465450402021-12-17U-3Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021742-00565450402021-12-17U-3Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021742-00265450402021-12-17U-3Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021742-00365450402021-12-17U-3Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021742-00465450402021-12-17U-3Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021742-00565450402021-12-17U-3Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021742-00265450402021-12-17U-3Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021742-00365450402021-12-17U-3Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021742-00465450402021-12-17U-3Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021742-00565450402021-12-17U-3Drug productea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEBIVOLOL HYDROCHLORIDEACTIVE INGREDIENTJGS34J7L9IBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
NEBIVOLOLACTIVE MOIETY030Y90569UBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
hypromellosesINACTIVE INGREDIENT3NXW29V3WOBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
magnesium stearateINACTIVE INGREDIENT70097M6I30BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9
starch, cornINACTIVE INGREDIENTO8232NY3SJBYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]9

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BystolicNEBIVOLOL HYDROCHLORIDEAllergan, Inc.8b8ad213-1dc8-454e-a524-075685c0e1a82024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021742
application number: NDA021742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4621-2551544621021710 TABLET in 1 BOTTLE, PLASTIC (55154-4621-2) 1710 tablet2008-01-222023-06-30NoNoCurrent