Home NDC 10135-717-01 Sotalol Hydrochloride
Product NDC 10135-717
Requested package NDC 10135-717-01
11-digit product format 101350717
Labeler code 10135
Product ID 10135-717_b945b073-8372-826c-e053-2995a90ad9b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA207429
Marketing category ANDA
Marketing start 2020-10-01
Marketing end 0000-00-00
Substance SOTALOL HYDROCHLORIDE
Active strength 160 mg/1
Pharmacologic classes Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A207429-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 A207429-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 A207429-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02
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 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2018-11-02 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-717-01 Sotalol HydrochlorideAF 100 in 1 BOTTLE, PLASTIC TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-717 SOTALOL HYDROCHLORIDE AF (SOTALOL HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC] 4 Legacy NDC, 1 package rows 20210120_7c9cc47c-1cb2-405d-8c8a-50226482ede2.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 Sotalol SOTALOL HYDROCHLORIDE UNICHEM PHARMACEUTICALS (USA), INC. 56879738-8662-4f5c-8386-761ab2b5e46f 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207429 application number: ANDA207429
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 10135-717-01 10135071701 100 TABLET in 1 BOTTLE, PLASTIC (10135-717-01) 100 tablet 2020-10-01 0000-00-00 No No Current