FDA.reportPublic FDA data

Nebivolol

Product NDC
72162-2416
Requested package NDC
72162-2416-9
11-digit product format
721622416
Labeler code
72162
Product ID
72162-2416_02a4fc30-05ea-413a-89e5-a87a2bbf779b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208717
Marketing category
ANDA
Marketing start
2017-12-29
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208717-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2021-12-17a50c72e98297…
2026-08-01 22:54:322026-06A208717-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2021-12-17a50c72e98297…
2026-08-01 22:54:322026-06A208717-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2021-12-17a50c72e98297…
2026-08-01 22:54:322026-06A208717-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2021-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208717-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208717-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208717-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208717-004AB1a50c72e98297…

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
NebivololNEBIVOLOLBryant Ranch Prepack0ca84bf1-511d-480d-ba3d-0eef00ddad3e2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717
ndc (package): 72162-2416-9
ndc (product): 72162-2416
ndc11 (package): 72162241609
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
NebivololNEBIVOLOLCadila Pharmaceuticals Limited451cdd6e-13b4-402f-8a44-cdf5f7433a492023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208717
application number: ANDA208717

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
0ca84bf1-511d-480d-ba3d-0eef00ddad3eAvailable 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
72162-2416-3Nebivolol30 in 1 BOTTLETABLET30100
72162-2416-9Nebivolol90 in 1 BOTTLETABLET90100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2416-3EA - Each72162-24165c347758-d49c-4ee0-9da0-d4aa4d08876212024-12-10
72162-2416-9EA - Each72162-2416bb6017c8-7c9f-4efc-9e84-e48c6a4ba15212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2416NEBIVOLOL TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20241102_0ca84bf1-511d-480d-ba3d-0eef00ddad3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
827073nebivolol 20 MG Oral TabletPSN0ca84bf1-511d-480d-ba3d-0eef00ddad3e100
827073nebivolol 20 MG Oral TabletSCD0ca84bf1-511d-480d-ba3d-0eef00ddad3e100
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY0ca84bf1-511d-480d-ba3d-0eef00ddad3e100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2416-97216224160990 TABLET in 1 BOTTLE (72162-2416-9) 90 tablet2024-10-31NoNoCurrent