Home NDC 46708-402 NADOLOL
Product NDC 46708-402
11-digit product format 467080402
Labeler code 46708
Product ID 46708-402_0bd202e3-c673-4945-b828-1a5bc6a896ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NADOLOL
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA211763
Marketing category ANDA
Marketing start 2023-06-08
Substance NADOLOL
Active strength 20 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 A211763-001 NADOLOL NADOLOL 20MG TABLET / ORAL AB 2023-06-02 A211763-002 NADOLOL NADOLOL 40MG TABLET / ORAL AB 2023-06-02 A211763-003 NADOLOL NADOLOL 80MG TABLET / ORAL AB 2023-06-02
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 2 · 66 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 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211763-002 NADOLOL 40MG TABLET / ORAL AB 2023-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211763-003 NADOLOL 80MG TABLET / ORAL AB 2023-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211763-001 NADOLOL 20MG TABLET / ORAL AB 2023-06-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 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 · 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 46708-402-30 NADOLOL 30 in 1 BOTTLE TABLET 30 1 46708-402-31 NADOLOL 100 in 1 BOTTLE TABLET 100 1 46708-402-91 NADOLOL 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-402 NADOLOL TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 3 package rows 20230615_0bd202e3-c673-4945-b828-1a5bc6a896ae.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 Sample Exclude flag Status 46708-402-30 46708040230 30 TABLET in 1 BOTTLE (46708-402-30) 30 tablet 2023-06-08 No No Current 46708-402-31 46708040231 100 TABLET in 1 BOTTLE (46708-402-31) 100 tablet 2023-06-08 No No Current 46708-402-91 46708040291 1000 TABLET in 1 BOTTLE (46708-402-91) 1000 tablet 2023-06-08 No No Current