Home NDC 71335-1189 Sotalol
Product NDC 71335-1189
11-digit product format 713351189
Labeler code 71335
Product ID 71335-1189_ca49d506-4490-469e-8084-b687dd488a88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207428
Marketing category ANDA
Marketing start 2017-12-15
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 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 · 8 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 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 71335-1189-3 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-1189-2 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-1189-1 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 71335-1189-3 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-1189-2 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-1189-1 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 A207428-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 A207428-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 A207428-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21
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 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207428-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2016-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207428-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2016-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207428-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2016-10-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sotalol
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1189-1 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-1 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-2 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-2 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-3 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-3 2024-05-20 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-1 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-1 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-2 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-2 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-3 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 71335-1189-3 2024-01-30 These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1189-1 Sotalol 60 in 1 BOTTLE TABLET 60 3 71335-1189-2 Sotalol 30 in 1 BOTTLE TABLET 30 3 71335-1189-3 Sotalol 100 in 1 BOTTLE TABLET 100 3 71335-1189-4 Sotalol 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1189 SOTALOL (SOTALOL HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK] 3 Current NDC, Legacy NDC, 4 package rows 20240522_c824f6b2-80c5-45a6-a491-4c14c9f5e33d.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sotalol SOTALOL HYDROCHLORIDE Bryant Ranch Prepack c824f6b2-80c5-45a6-a491-4c14c9f5e33d 2026-06-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207428 application number: ANDA207428 ndc (product): 71335-1189 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): 207428 application number: ANDA207428 Sotalol SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 282b48b2-f9ff-474a-b01e-68a9ce5edf07 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207428 application number: ANDA207428 Sotalol SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 51cebe16-4496-4f49-b2db-b7b21c08fa23 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207428 application number: ANDA207428 Sotalol SOTALOL HYDROCHLORIDE Bryant Ranch Prepack 5962c4ee-c8f7-4e38-ab8c-4848c7644362 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207428 application number: ANDA207428
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 71335-1189-1 71335118901 60 TABLET in 1 BOTTLE (71335-1189-1) 60 tablet 2019-04-15 0000-00-00 No No Current 71335-1189-2 71335118902 30 TABLET in 1 BOTTLE (71335-1189-2) 30 tablet 2019-04-22 0000-00-00 No No Current 71335-1189-3 71335118903 100 TABLET in 1 BOTTLE (71335-1189-3) 100 tablet 2024-05-17 0000-00-00 No No Current 71335-1189-4 71335118904 90 TABLET in 1 BOTTLE (71335-1189-4) 90 tablet 2024-05-17 No No Current