FDA.reportPublic FDA data

Nebivolol

Product NDC
70518-3527
Requested package NDC
70518-3527-0
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

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203828-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2015-07-29a50c72e98297…
2026-08-01 22:54:322026-06A203828-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2015-07-29a50c72e98297…
2026-08-01 22:54:322026-06A203828-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2015-07-29a50c72e98297…
2026-08-01 22:54:322026-06A203828-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2015-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203828-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203828-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A203828-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A203828-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 70518-3527-0
ndc (product): 70518-3527
ndc11 (package): 70518352700
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

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

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