Nebivolol

Product NDC
50090-5761
11-digit product format
500905761
Labeler code
50090
Product ID
50090-5761_26df2438-2d17-4683-b43d-68e6605495b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203828
Marketing category
ANDA
Marketing start
2021-09-16
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
10 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

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 packagepackage50090-576150090-5761-1DDiscontinued 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
A203828-001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29
A203828-002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29
A203828-003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29
A203828-004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203828-001AB
A203828-002AB
A203828-003AB
A203828-004AB

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 UTC2026-02A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203828-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203828-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203828-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203828-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203828-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203828-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203828-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203828-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203828-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203828-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203828-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203828-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JGS34J7L9IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
751612Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdd7a3c5-d3dd-4a89-97d7-642f96eda21bAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5761-02023-02-06These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
50090-5761-12023-02-06These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
50090-5761-22023-02-06These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
50090-5761-02023-01-30These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
50090-5761-12023-01-30These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
50090-5761-22023-01-30These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5761-0Nebivolol30 in 1 BOTTLETABLET305
50090-5761-1Nebivolol60 in 1 BOTTLETABLET605
50090-5761-2Nebivolol90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5761-0EA - Each50090-5761ad77444e-fab1-4afe-a6e6-5192a023b26e12025-01-14
50090-5761-2EA - Each50090-576140e8c6b5-315d-42db-a937-a67b788eaeaf12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5761NEBIVOLOL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20231204_cdd7a3c5-d3dd-4a89-97d7-642f96eda21b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NebivololNEBIVOLOLA-S Medication Solutionsf85d7b19-51d9-47d9-bd7b-13d45ad7759b2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
NebivololNEBIVOLOLREMEDYREPACK INC.3745fc9d-cd3f-4877-bef0-81d9a9a057862026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
NebivololNEBIVOLOLAscend Laboratories, LLCfecef8fc-b66b-4133-b66f-8d6b727506222025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
NebivololNEBIVOLOLAmerican Health Packaging5418f2b2-3e23-4e7a-b4df-36a1515c9a122025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
NebivololNEBIVOLOLA-S Medication Solutions5953f23b-2f41-4b49-bcdb-1691f4ffa35f2025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
NebivololNEBIVOLOLA-S Medication Solutionscdd7a3c5-d3dd-4a89-97d7-642f96eda21b2023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203828
application number: ANDA203828
ndc (product): 50090-5761

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5
751612nebivolol 10 MG Oral TabletSCDcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5761-05009057610030 TABLET in 1 BOTTLE (50090-5761-0) 30 tablet2021-10-010000-00-00NoNoCurrent
50090-5761-15009057610160 TABLET in 1 BOTTLE (50090-5761-1) 60 tablet2021-10-070000-00-00NoNoCurrent
50090-5761-25009057610290 TABLET in 1 BOTTLE (50090-5761-2) 90 tablet2021-10-070000-00-00NoNoCurrent