Home NDC 10135-715 Sotalol Hydrochloride
Product NDC 10135-715
11-digit product format 101350715
Labeler code 10135
Product ID 10135-715_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 80 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10135-715-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10135-715-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10135-715-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10135-715-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10135-715-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10135-715-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10135-715-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10135-715-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10135-715-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10135-715-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10135-715-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10135-715-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10135-715-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10135-715-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10135-715-01 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 10135-715-01 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 10135-715 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 10135-715-01 10135071501 100 TABLET in 1 BOTTLE, PLASTIC (10135-715-01) 100 tablet 2020-10-01 0000-00-00 No No Current