Nebivolol

Product NDC
70518-3527
11-digit product format
705183527
Labeler code
70518
Product ID
70518-3527_48be4213-e2e2-10b7-e063-6294a90aee17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203828
Marketing category
ANDA
Marketing start
2022-09-20
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
2027-12-31
Current FDA listing
Yes

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 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3527-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3527-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3527-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3527-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3527-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3527-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3527-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3527-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3527-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3527-0ad56d346431e…cc804d4bbf1e…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE5 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
387013Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3745fc9d-cd3f-4877-bef0-81d9a9a05786Available 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
70518-3527-0Nebivolol90 in 1 BOTTLE, PLASTICTABLET905

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
ndc (product): 70518-3527
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSN3745fc9d-cd3f-4877-bef0-81d9a9a057865
387013nebivolol 5 MG Oral TabletSCD3745fc9d-cd3f-4877-bef0-81d9a9a057865
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3745fc9d-cd3f-4877-bef0-81d9a9a057865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3527-07051835270090 TABLET in 1 BOTTLE, PLASTIC (70518-3527-0) 90 tablet2022-09-200000-00-00NoNoCurrent