Home NDC 72162-2584 SOTALOL HYDROCHLORIDE
Product NDC 72162-2584
11-digit product format 721622584
Labeler code 72162
Product ID 72162-2584_dd32cb85-542d-4c28-9f40-c71c46c9197b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SOTALOL HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075500
Marketing category ANDA
Marketing start 2025-11-01
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075500-001 SORINE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2001-04-27 A075500-002 SORINE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2001-04-27 A075500-003 SORINE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2001-04-27 A075500-004 SORINE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2001-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075500-001 SORINE 80MG TABLET / ORAL AB 2001-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075500-002 SORINE 160MG TABLET / ORAL AB 2001-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075500-003 SORINE 240MG TABLET / ORAL AB 2001-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075500-004 SORINE 120MG TABLET / ORAL AB 2001-04-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1923422 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 72162-2584-1 SOTALOL HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 100
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 44d0ce4c-de00-4151-ad7f-48a59040a9b0 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075500 application number: ANDA075500 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 56dd490f-4d78-447c-a460-f55587e8a764 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075500 application number: ANDA075500 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 14ee4756-52f2-4bbf-bd79-663839ecb1c5 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075500 application number: ANDA075500 ndc (product): 72162-2584 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE Bryant Ranch Prepack db9b0b36-4c00-45b6-a50a-e08d7c61a17c 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075500 application number: ANDA075500 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE AiPing Pharmaceutical, Inc. 56326224-fc80-4b89-8ba3-70cb873173b4 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075500 application number: ANDA075500
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2584-1 72162258401 100 TABLET in 1 BOTTLE (72162-2584-1) 100 tablet 2025-11-24 No No Current