Home NDC 76385-127 Sotalol Hydrochloride
Product NDC 76385-127
11-digit product format 763850127
Labeler code 76385
Product ID 76385-127_fe9ac463-547d-4917-a98e-61f1c0fe38f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride Tablets AF
Dosage form TABLET
Route ORAL
Labeler UNICHEM PHARMACEUTICALS (USA), INC.
Application ANDA207429
Marketing category ANDA
Marketing start 2020-02-21
Substance SOTALOL HYDROCHLORIDE
Active strength 160 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
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 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 A207429-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 A207429-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 A207429-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02
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 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 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 Sotalol Hydrochloride
Brand name suffix AF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOTALOL HYDROCHLORIDE 160 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922720 Internal RxNorm lookup 1922763 Internal RxNorm lookup 1922765 Internal RxNorm lookup 1923422 Internal RxNorm lookup 1923424 Internal RxNorm lookup 1923426 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 76385-127-01 Sotalol HydrochlorideAF 100 in 1 BOTTLE, PLASTIC TABLET 100 5 76385-127-50 Sotalol HydrochlorideAF 500 in 1 BOTTLE, PLASTIC TABLET 500 5 76385-127-01 Sotalol HydrochlorideAF 100 in 1 BOTTLE, PLASTIC TABLET 100 2 76385-127-50 Sotalol HydrochlorideAF 500 in 1 BOTTLE, PLASTIC TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76385-127 SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE TABLES AF) TABLET SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE TABLETS AF) TABLET [BAYSHORE PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240118_2577dd8d-ab1b-4a55-990a-18c69395edfe.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sotalol SOTALOL HYDROCHLORIDE UNICHEM PHARMACEUTICALS (USA), INC. 56879738-8662-4f5c-8386-761ab2b5e46f 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207429 application number: ANDA207429 ndc (product): 76385-127
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 76385-127-01 76385012701 100 TABLET in 1 BOTTLE, PLASTIC (76385-127-01) 100 tablet 2020-02-21 0000-00-00 No No Current 76385-127-50 76385012750 500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50) 500 tablet 2020-02-21 0000-00-00 No No Current