Nebivolol

Product NDC
67877-390
11-digit product format
678770390
Labeler code
67877
Product ID
67877-390_4f315a54-2598-4463-8884-0b643e86f8c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA203828
Marketing category
ANDA
Marketing start
2021-09-16
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

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 HYDROCHLORIDE20 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
fecef8fc-b66b-4133-b66f-8d6b72750622Available 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
67877-390-01Nebivolol100 in 1 BOTTLETABLET10018
67877-390-30Nebivolol30 in 1 BOTTLETABLET3018
67877-390-33Nebivolol10 in 1 BLISTER PACKTABLET1018
67877-390-33Nebivolol1 in 1 CARTONTABLET118
67877-390-90Nebivolol90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-390-30EA - Each67877-390bd1dc898-ad5e-41d3-8a6f-6c3fc87cec3412021-10-08
67877-390-90EA - Each67877-390cd0cc803-fc8f-4eab-a439-820a2936769e12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-390NEBIVOLOL TABLET [ASCEND LABORATORIES, LLC]17Current NDC, Legacy NDC, 5 package rows20241122_fecef8fc-b66b-4133-b66f-8d6b72750622.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
ndc (product): 67877-390
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol 2.5 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol 20 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol 5 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
751612nebivolol 10 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol 2.5 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol 20 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol 5 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-390-0167877039001100 TABLET in 1 BOTTLE (67877-390-01) 100 tablet2021-09-160000-00-00NoNoCurrent
67877-390-306787703903030 TABLET in 1 BOTTLE (67877-390-30) 30 tablet2021-09-160000-00-00NoNoCurrent
67877-390-33678770390331 BLISTER PACK in 1 CARTON (67877-390-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2021-09-160000-00-00NoNoCurrent
67877-390-906787703909090 TABLET in 1 BOTTLE (67877-390-90) 90 tablet2021-09-160000-00-00NoNoCurrent