Home NDC 42806-121 Sotalol hydrochloride
Product NDC 42806-121
11-digit product format 428060121
Labeler code 42806
Product ID 42806-121_34ed0846-81bd-46c4-a57c-b617c7d8232d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sotalol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA077070
Marketing category ANDA
Marketing start 2016-01-04
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 A077070-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 A077070-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 A077070-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04
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 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077070-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2005-11-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077070-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2005-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077070-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2005-11-04 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
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 42806-121-01 Sotalol hydrochloride 100 in 1 BOTTLE TABLET 100 9 42806-121-10 Sotalol hydrochloride 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-121 SOTALOL HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241222_c0a34c56-9641-4592-9754-bcc233ec86b6.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 Marketing end Sample Exclude flag Status 42806-121-01 42806012101 100 TABLET in 1 BOTTLE (42806-121-01) 100 tablet 2016-01-04 0000-00-00 No No Current 42806-121-10 42806012110 1000 TABLET in 1 BOTTLE (42806-121-10) 1000 tablet 2016-01-04 0000-00-00 No No Current