Home NDC 59651-775 SOTALOL HYDROCHLORIDE
Product NDC 59651-775
11-digit product format 596510775
Labeler code 59651
Product ID 59651-775_8a142042-e510-4232-8f20-5c92a991bd91
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SOTALOL HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077616
Marketing category ANDA
Marketing start 2023-06-29
Substance SOTALOL HYDROCHLORIDE
Active strength 80 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
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 A077616-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 A077616-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 A077616-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07
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 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 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077616-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2007-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077616-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2007-02-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SOTALOL HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOTALOL HYDROCHLORIDE 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HEC37C70XX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922720 Internal RxNorm lookup 1922763 Internal RxNorm lookup 1922765 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 59651-775-01 SOTALOL HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-775 SOTALOL HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] 2 Current NDC, 1 package rows 20241004_6f3145d7-f3c9-4456-a77d-d04c54f24668.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 · 1 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 59651-775-01 59651077501 100 TABLET in 1 BOTTLE (59651-775-01) 100 tablet 2023-06-29 No No Current