NEBIVOLOL

Product NDC
0904-7497
11-digit product format
009047497
Labeler code
0904
Product ID
0904-7497_2562c60f-8883-417d-a6db-01f4f243b199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212682
Marketing category
ANDA
Marketing start
2025-02-24
Substance
NEBIVOLOL
Active strength
2.5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A212682-001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07
A212682-002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07
A212682-003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07
A212682-004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212682-001AB
A212682-002AB
A212682-003AB
A212682-004AB

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 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212682-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2022-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2022-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2022-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2022-04-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212682-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212682-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212682-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212682-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212682-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212682-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212682-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212682-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212682-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212682-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212682-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212682-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212682-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
NEBIVOLOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
030Y90569UInternal 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
3e9e1048-b5ea-4d6a-9363-3ee0d059e088Available 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
0904-7497-04NEBIVOLOL1 in 1 BLISTER PACKTABLET14
0904-7497-04NEBIVOLOL30 in 1 CARTONTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7497-04EA - Each0904-749787a93dee-3150-4bfe-94ac-2cad65ece92812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7497NEBIVOLOL TABLET [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20250410_3e9e1048-b5ea-4d6a-9363-3ee0d059e088.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEBIVOLOLNEBIVOLOLMajor Pharmaceuticals3e9e1048-b5ea-4d6a-9363-3ee0d059e0882026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
ndc (product): 0904-7497
NEBIVOLOLNEBIVOLOLSolco Healthcare US, LLC51d3f12f-94cc-4f58-94d3-61990e16adfc2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIVOLOLREMEDYREPACK INC.a9bad35e-cd48-48f1-93ca-46490dbf70a82025-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIVOLOLBryant Ranch Prepack126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NebivololNEBIVOLOLDirect_Rx25b5631c-44a3-05b4-e063-6394a90aeb7d2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIVOLOLA-S Medication Solutionsf20fda1a-437d-4812-b519-a26684c96c6d2024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIBOLOLBryant Ranch Prepack78c0945a-b8dc-4397-95d5-9f209224ad5e2024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIVOLOLBryant Ranch Prepack77fb6b5f-7bfe-4fc8-980c-fc688ac9837a2024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682
NEBIVOLOLNEBIBOLOLA-S Medication Solutions9b131f61-bed0-481b-a96e-3126958f9a9b2024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212682
application number: ANDA212682

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol 10 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7497-040090474970430 BLISTER PACK in 1 CARTON (0904-7497-04) / 1 TABLET in 1 BLISTER PACK30 blister pack2025-02-24NoNoCurrent