Nebivolol

Product NDC
72241-032
11-digit product format
722410032
Labeler code
72241
Product ID
72241-032_53d2f49b-b0b8-46fc-b80d-1ac3756e7e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA208717
Marketing category
ANDA
Marketing start
2017-12-29
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
2.5 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

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
A208717-001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17
A208717-002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17
A208717-003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17
A208717-004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208717-001AB
A208717-002AB
A208717-003AB
A208717-004AB

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 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208717-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208717-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208717-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208717-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208717-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208717-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208717-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208717-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208717-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208717-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208717-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208717-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208717-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE2.5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387013Internal RxNorm lookup
751612Internal RxNorm lookup
751618Internal RxNorm lookup
827073Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
19d20396-ade8-400e-94f4-69913637d051Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72241-032-04Nebivolol90 in 1 BOTTLETABLET904
72241-032-05Nebivolol100 in 1 BOTTLETABLET1004
72241-032-11Nebivolol1000 in 1 BOTTLETABLET10004
72241-032-22Nebivolol30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-032-22EA - Each72241-032be800c58-963b-4499-bdff-1cd0e9a1488d12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-032NEBIVOLOL TABLET [MODAVAR PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231110_19d20396-ade8-400e-94f4-69913637d051.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
NebivololNEBIVOLOLBryant Ranch Prepack0ca84bf1-511d-480d-ba3d-0eef00ddad3e2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
NebivololNEBIVOLOLBryant Ranch Prepack04a64dad-6922-4737-ab46-98c185782b382024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
NebivololNEBIVOLOLBryant Ranch Prepackabb0546f-08dd-4354-8b41-d17065b52c242024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
NebivololNEBIVOLOLBryant Ranch Prepack9a5e1bd8-f2b6-42e6-972d-09418528cd632024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
NebivololNEBIVOLOLModavar Pharmaceuticals LLC19d20396-ade8-400e-94f4-69913637d0512023-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
ndc (product): 72241-032
NebivololNEBIVOLOLCadila Pharmaceuticals Limited451cdd6e-13b4-402f-8a44-cdf5f7433a492023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751618nebivolol 2.5 MG Oral TabletPSNabb0546f-08dd-4354-8b41-d17065b52c24101
751618nebivolol 2.5 MG Oral TabletSCDabb0546f-08dd-4354-8b41-d17065b52c24101
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYabb0546f-08dd-4354-8b41-d17065b52c24101
751612nebivolol 10 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol 2.5 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol 20 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol 5 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
751612nebivolol 10 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol 2.5 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol 20 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol 5 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-032-047224100320490 TABLET in 1 BOTTLE (72241-032-04) 90 tablet2021-12-180000-00-00NoNoCurrent
72241-032-0572241003205100 TABLET in 1 BOTTLE (72241-032-05) 100 tablet2021-12-180000-00-00NoNoCurrent
72241-032-11722410032111000 TABLET in 1 BOTTLE (72241-032-11) 1000 tablet2021-12-180000-00-00NoNoCurrent
72241-032-227224100322230 TABLET in 1 BOTTLE (72241-032-22) 30 tablet2021-12-180000-00-00NoNoCurrent