Home NDC 50090-7995 Nadolol
Product NDC 50090-7995
11-digit product format 500907995
Labeler code 50090
Product ID 50090-7995_b5fb5f65-567f-4bdb-94f3-c3520f59200b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nadolol
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA208832
Marketing category ANDA
Marketing start 2017-06-02
Substance NADOLOL
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 43 .
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 · 129 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 2026-09-14 22:38:34 2026-08 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208832-001 NADOLOL 20MG TABLET / ORAL AB 2017-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208832-002 NADOLOL 40MG TABLET / ORAL AB 2017-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208832-003 NADOLOL 80MG TABLET / ORAL AB 2017-06-02 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nadolol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NADOLOL 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198006 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-7995-0 50090799500 30 TABLET in 1 BOTTLE (50090-7995-0) 30 tablet 2026-06-15 No No Current 50090-7995-1 50090799501 90 TABLET in 1 BOTTLE (50090-7995-1) 90 tablet 2026-06-15 No No Current