Home NDC 31722-585 Nebivolol
Product NDC 31722-585
11-digit product format 317220585
Labeler code 31722
Product ID 31722-585_103af555-44dd-5dfb-e063-6294a90a259f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nebivolol
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203825
Marketing category ANDA
Marketing start 2021-09-17
Substance NEBIVOLOL HYDROCHLORIDE
Active strength 2.5 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 A203825-001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 A203825-002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 A203825-003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 A203825-004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03
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 4 · 144 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 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203825-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2020-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203825-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2020-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203825-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2020-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203825-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2020-11-03 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nebivolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEBIVOLOL HYDROCHLORIDE 2.5 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-585 NEBIVOLOL (NEBIVOLOL) TABLET [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 6 package rows 20240201_202d5142-6180-4d48-9a9f-1bd6992fc49b.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 31722-585-01 31722058501 100 TABLET in 1 BOTTLE (31722-585-01) 100 tablet 2021-09-17 0000-00-00 No No Current 31722-585-30 31722058530 30 TABLET in 1 BOTTLE (31722-585-30) 30 tablet 2021-09-17 0000-00-00 No No Current 31722-585-31 31722058531 10 in 1 BLISTER PACK Historical 31722-585-32 31722058532 12 BLISTER PACK in 1 CARTON (31722-585-32) / 10 TABLET in 1 BLISTER PACK (31722-585-31) 12 blister pack 2021-09-17 0000-00-00 No No Current 31722-585-33 31722058533 10 in 1 BLISTER PACK Historical 31722-585-34 31722058534 15 BLISTER PACK in 1 CARTON (31722-585-34) / 10 TABLET in 1 BLISTER PACK (31722-585-33) 15 blister pack 2021-09-17 0000-00-00 No No Current