Home NDC 71205-046 Sotalol Hydrochloride
Product NDC 71205-046
11-digit product format 712050046
Labeler code 71205
Product ID 71205-046_8fd472ad-bdc0-4672-b67c-658ce12aafc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA075429
Marketing category ANDA
Marketing start 2000-05-04
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075429-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 A075429-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 A075429-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 A075429-004 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01
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 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71205-046-30 Sotalol Hydrochloride 30 in 1 BOTTLE TABLET 30 5 71205-046-60 Sotalol Hydrochloride 60 in 1 BOTTLE TABLET 60 5 71205-046-90 Sotalol Hydrochloride 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-046 SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 3 package rows 20241024_6acf10b5-bbd9-4993-99a9-2cdb8cec96c5.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 31404462-7fa0-20d6-e063-6294a90aa58c 2025-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429 Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Proficient Rx LP 6acf10b5-bbd9-4993-99a9-2cdb8cec96c5 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429 ndc (product): 71205-046 Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 8e2772cb-7dea-42d1-ba31-d479ba7cb09a 2023-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429
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 71205-046-30 71205004630 30 TABLET in 1 BOTTLE (71205-046-30) 30 tablet 2018-06-01 0000-00-00 No No Current 71205-046-60 71205004660 60 TABLET in 1 BOTTLE (71205-046-60) 60 tablet 2018-06-01 0000-00-00 No No Current 71205-046-90 71205004690 90 TABLET in 1 BOTTLE (71205-046-90) 90 tablet 2018-06-01 0000-00-00 No No Current