Home NDC 59651-252 Nadolol
Product NDC 59651-252
11-digit product format 596510252
Labeler code 59651
Product ID 59651-252_bfed393e-1baf-439a-8073-998c1a97b276
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nadolol
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA201893
Marketing category ANDA
Marketing start 2021-10-29
Substance NADOLOL
Active strength 80 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201893-001 NADOLOL NADOLOL 40MG TABLET / ORAL AB 2015-09-16 A201893-002 NADOLOL NADOLOL 80MG TABLET / ORAL AB 2015-09-16 A201893-003 NADOLOL NADOLOL 20MG TABLET / ORAL AB 2022-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 110 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 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201893-002 NADOLOL 80MG TABLET / ORAL AB 2015-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201893-003 NADOLOL 20MG TABLET / ORAL AB 2022-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201893-001 NADOLOL 40MG TABLET / ORAL AB 2015-09-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 110 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nadolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NADOLOL 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FEN504330V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198006 Internal RxNorm lookup 198007 Internal RxNorm lookup 198008 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 59651-252-01 Nadolol 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-252 NADOLOL TABLET [AUROBINDO PHARMA LIMITED] 5 Current NDC, Legacy NDC, 1 package rows 20240130_44c5352d-89f8-4bd3-9479-1069304562ca.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 · 3 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 59651-252-01 59651025201 100 TABLET in 1 BOTTLE (59651-252-01) 100 tablet 2021-10-29 0000-00-00 No No Current