Home NDC 83107-010 BETAPACE AF
Product NDC 83107-010
11-digit product format 831070010
Labeler code 83107
Product ID 83107-010_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sotalol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Legacy Pharma USA, Inc.
Application NDA019865
Marketing category NDA
Marketing start 2016-09-01
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 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019865-001 BETAPACE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB RLD 1992-10-30 N019865-002 BETAPACE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 N019865-003 BETAPACE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB RLD 1992-10-30 N019865-004 BETAPACE SOTALOL HYDROCHLORIDE 320MG TABLET / ORAL 1992-10-30 N019865-005 BETAPACE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB RLD 1994-04-20
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 6 · 205 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 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-001 BETAPACE 80MG TABLET / ORAL AB RLD 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-002 BETAPACE 160MG TABLET / ORAL AB RLD, RS 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-003 BETAPACE 240MG TABLET / ORAL AB RLD 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-004 BETAPACE 320MG TABLET / ORAL 1992-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019865-005 BETAPACE 120MG TABLET / ORAL AB RLD 1994-04-20 5bbf6a4d5a75…
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 BETAPACE AF
Listing expiration 2026-12-31 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 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922720 Internal RxNorm lookup 1922721 Internal RxNorm lookup 1922763 Internal RxNorm lookup 1922764 Internal RxNorm lookup 1922765 Internal RxNorm lookup 1922766 Internal RxNorm lookup 1923422 Internal RxNorm lookup 1923423 Internal RxNorm lookup 1923424 Internal RxNorm lookup 1923425 Internal RxNorm lookup 1923426 Internal RxNorm lookup 1923427 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 83107-010-60 BETAPACE AF 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83107-010 BETAPACE (SOTALOL HYDROCHLORIDE) TABLET BETAPACE AF (SOTALOL HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.] 2 Current NDC, 1 package rows 20241220_a6a7702f-36c9-45db-b640-453dc324baee.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 BETAPACE SOTALOL HYDROCHLORIDE Legacy Pharma USA, Inc. a6a7702f-36c9-45db-b640-453dc324baee 2024-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019865 application number: NDA019865 ndc (product): 83107-010
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83107-010-60 83107001060 60 TABLET in 1 BOTTLE (83107-010-60) 60 tablet 2016-09-01 No No Current