Home NDC 69724-112 Sotalol hydrochloride
Product NDC 69724-112
11-digit product format 697240112
Labeler code 69724
Product ID 69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler ALTATHERA Pharmaceuticals, LLC
Application NDA022306
Marketing category NDA
Marketing start 2015-10-15
Substance SOTALOL HYDROCHLORIDE
Active strength 15 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022306-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022306-001 12403109 2028-08-14 U-2769 2025-09-12 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 N022306-001 12390431 2038-08-14 U-2769 2025-09-04 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 N022306-001 12569183 2039-04-05 U-4456 2026-04-09 N022306-001 11583216 2039-08-21 U-3549 2023-03-27
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 2 · 41 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 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022306-001 SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-07-02 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 166 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022306-001 12403109 2028-08-14 U-2769 2025-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 12390431 2038-08-14 U-2769 2025-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 12403109 2028-08-14 U-2769 2025-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 12390431 2038-08-14 U-2769 2025-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 10512620 2038-08-14 U-2769 2020-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 10512620 2038-08-14 U-3547 2020-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 11696902 2038-08-14 U-2769 2023-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 10799138 2039-04-05 U-3549 2021-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 10799138 2039-04-05 U-3125 2021-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022306-001 11583216 2039-08-21 U-3549 2023-03-27 03ed91905a0d…
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 15 mg/mL
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 904630 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 69724-112-10 Sotalol hydrochloride 1 in 1 CARTON INJECTION 1 15 69724-112-10 Sotalol hydrochloride 10 mL in 1 VIAL INJECTION 10 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69724-112 SOTALOL HYDROCHLORIDE INJECTION [ALTATHERA PHARMACEUTICALS, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20231006_ff3061ab-d930-4318-a5be-684e38be229e.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.
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 69724-112-10 69724011210 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL 1 vial 2015-10-15 0000-00-00 No No Current