Home NDC 33342-458 Nebivolol
Product NDC 33342-458
11-digit product format 333420458
Labeler code 33342
Product ID 33342-458_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nebivolol
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA212661
Marketing category ANDA
Marketing start 2019-01-19
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212661-001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 A212661-002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 A212661-003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 A212661-004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28
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.
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 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212661-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2025-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212661-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212661-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2025-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212661-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2025-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nebivolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEBIVOLOL HYDROCHLORIDE 5 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 33342-458-07 Nebivolol 30 in 1 BOTTLE TABLET 30 1 33342-458-10 Nebivolol 90 in 1 BOTTLE TABLET 90 1 33342-458-25 Nebivolol 12 in 1 CARTON TABLET 12 1 33342-458-25 Nebivolol 10 in 1 BLISTER PACK TABLET 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-458 NEBIVOLOL TABLET [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20250528_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e.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 33342-458-07 33342045807 30 TABLET in 1 BOTTLE (33342-458-07) 30 tablet 2025-01-29 No No Current 33342-458-10 33342045810 90 TABLET in 1 BOTTLE (33342-458-10) 90 tablet 2025-01-29 No No Current 33342-458-25 33342045825 12 BLISTER PACK in 1 CARTON (33342-458-25) / 10 TABLET in 1 BLISTER PACK 12 blister pack 2025-01-29 No No Current