Home NDC 69238-1125 Nadolol
Product NDC 69238-1125
11-digit product format 692381125
Labeler code 69238
Product ID 69238-1125_c1092e52-cd19-48ff-8c50-476c5243667a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nadolol
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208832
Marketing category ANDA
Marketing start 2017-06-02
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 A208832-001 NADOLOL NADOLOL 20MG TABLET / ORAL AB 2017-06-02 A208832-002 NADOLOL NADOLOL 40MG TABLET / ORAL AB 2017-06-02 A208832-003 NADOLOL NADOLOL 80MG TABLET / ORAL AB 2017-06-02
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 4 · 123 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 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nadolol
Listing expiration 2027-12-31 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 69238-1125-1 Nadolol 1000 in 1 BOTTLE TABLET 1000 9 69238-1125-3 Nadolol 30 in 1 BOTTLE TABLET 30 9 69238-1125-9 Nadolol 90 in 1 BOTTLE TABLET 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1125 NADOLOL TABLET [AMNEAL PHARMACEUTICALS NY LLC] 9 Current NDC, Legacy NDC, 3 package rows 20241011_e2e24b14-0169-4028-828a-894ad3c2ba55.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 Marketing end Sample Exclude flag Status 69238-1125-1 69238112501 1000 TABLET in 1 BOTTLE (69238-1125-1) 1000 tablet 2017-06-02 0000-00-00 No No Current 69238-1125-3 69238112503 30 TABLET in 1 BOTTLE (69238-1125-3) 30 tablet 2017-06-02 0000-00-00 No No Current 69238-1125-9 69238112509 90 TABLET in 1 BOTTLE (69238-1125-9) 90 tablet 2017-06-02 0000-00-00 No No Current