Home NDC 60505-0223 Sotalol Hydrochloride
Product NDC 60505-0223
11-digit product format 605050223
Labeler code 60505
Product ID 60505-0223_7e1fd07e-45aa-ef32-da1b-c81f6961f216
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA076214
Marketing category ANDA
Marketing start 2003-09-09
Substance SOTALOL HYDROCHLORIDE
Active strength 120 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 A076214-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 A076214-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 A076214-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27
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 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076214-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2003-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076214-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2003-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076214-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2003-08-27 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 120 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904589 Internal RxNorm lookup 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 60505-0223-1 Sotalol Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 17 60505-0223-2 Sotalol Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET 1000 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0223 SOTALOL HYDROCHLORIDE TABLET [APOTEX CORP.] 16 Current NDC, Legacy NDC, 2 package rows 20241003_1a56c82e-7ecd-43b0-2899-f89e47adf7db.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 · 2 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 60505-0223-1 60505022301 100 TABLET in 1 BOTTLE, PLASTIC (60505-0223-1) 100 tablet 2003-09-09 0000-00-00 No No Current 60505-0223-2 60505022302 1000 TABLET in 1 BOTTLE, PLASTIC (60505-0223-2) 1000 tablet 2003-09-09 0000-00-00 No No Current