Home NDC 69025-000 NADOLOL
Product NDC 69025-000
11-digit product format 690250000
Labeler code 69025
Product ID 69025-000_b968eb86-12b8-6681-e053-2a95a90a62fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NADOLOL
Dosage form TABLET
Route ORAL
Labeler Aizant Drug Research Solutions Pvt Ltd
Application ANDA212856
Marketing category ANDA
Marketing start 2020-06-30
Marketing end 0000-00-00
Substance NADOLOL
Active strength 20 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 A212856-001 NADOLOL NADOLOL 20MG TABLET / ORAL AB 2019-09-13 A212856-002 NADOLOL NADOLOL 40MG TABLET / ORAL AB 2019-09-13 A212856-003 NADOLOL NADOLOL 80MG TABLET / ORAL AB 2019-09-13
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 · 117 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 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212856-002 NADOLOL 40MG TABLET / ORAL AB 2019-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212856-003 NADOLOL 80MG TABLET / ORAL AB 2019-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212856-001 NADOLOL 20MG TABLET / ORAL AB 2019-09-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NADOLOL NADOLOL VGYAAN Pharmaceuticals LLC 85b4b931-51c4-4326-88ea-708dde8323d4 2023-09-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212856 application number: ANDA212856
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69025-000-00 69025000000 100 TABLET in 1 BOTTLE, PLASTIC (69025-000-00) 100 tablet 2020-06-30 0000-00-00 No No Current