Home NDC 0185-0171 sotalol hydrochloride
Product NDC 0185-0171
11-digit product format 001850171
Labeler code 0185
Product ID 0185-0171_401b80f7-8916-4421-be5f-e0647f553c88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sotalol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA075366
Marketing category ANDA
Marketing start 2000-05-01
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 2019-12-31
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 · 52 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0171-09 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0171-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0171-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0171-09 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0171-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0171-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0171-09 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0171-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0171-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0171-09 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0171-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0171-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0171-09 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0171-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0171-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0171-09 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0171-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0171-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0171-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0171-05 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0171-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0171-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0171-05 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0171-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0171-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0171-05 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0171-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0171-09 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0171-05 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0171-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0171-09 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0171-05 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0171-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0171-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0171-05 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0171-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0185-0171-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0185-0171-05 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0185-0171-09 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A075366-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 A075366-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 A075366-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 A075366-004 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01
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 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075366-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075366-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075366-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075366-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL 2000-05-01 d06236e962d9…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SOTALOL HYDROCHLORIDE ACTIVE INGREDIENT HEC37C70XX SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 SOTALOL ACTIVE MOIETY A6D97U294I SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SOTALOL HYDROCHLORIDE TABLET [EON LABS, INC.] 18 SOTALOL HYDROCHLORIDE ACTIVE INGREDIENT HEC37C70XX SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SOTALOL HYDROCHLORIDE ACTIVE INGREDIENT HEC37C70XX SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SOTALOL ACTIVE MOIETY A6D97U294I SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SOTALOL ACTIVE MOIETY A6D97U294I SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SOTALOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SOTALOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed RxNorm Mappings#