Home NDC 42291-874 nebivolol
Product NDC 42291-874
11-digit product format 422910874
Labeler code 42291
Product ID 42291-874_48842030-a03d-fb38-e063-6294a90a9dd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nebivolol hydrochloride
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA203821
Marketing category ANDA
Marketing start 2024-07-10
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203821-001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 A203821-002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 A203821-003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 A203821-004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203821-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203821-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203821-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203821-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2017-05-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base nebivolol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEBIVOLOL HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JGS34J7L9I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 387013 Internal RxNorm lookup 751612 Internal RxNorm lookup 751618 Internal RxNorm lookup 827073 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-874-90 nebivolol 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-874 NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) TABLET [AVKARE] 1 Current NDC, 1 package rows 20240712_1ce89dc5-018d-db40-e063-6294a90a9722.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-874-90 42291087490 90 TABLET in 1 BOTTLE (42291-874-90) 90 tablet 2024-07-10 No No Current