Home NDC 24338-530 SOTYLIZE
Product NDC 24338-530
11-digit product format 243380530
Labeler code 24338
Product ID 24338-530_73961d33-7149-49f3-8386-91f1b1758ca5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SOTALOL HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA205108
Marketing category NDA
Marketing start 2015-03-01
Substance SOTALOL HYDROCHLORIDE
Active strength 5 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 N205108-001 SOTYLIZE SOTALOL HYDROCHLORIDE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 N205108-001 12290495 2034-04-01 U-2096 2025-05-22 N205108-001 12290495 2034-04-01 U-2494 2025-05-22 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07
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 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205108-001 SOTYLIZE 5MG/ML (5MG/ML) SOLUTION / ORAL RLD, RS 2014-10-22 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 198 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 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 12290495 2034-04-01 U-2096 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 12290495 2034-04-01 U-2494 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 12290495 2034-04-01 U-2096 2025-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 12290495 2034-04-01 U-2494 2025-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 12290495 2034-04-01 U-2096 2025-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 12290495 2034-04-01 U-2494 2025-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 11850222 2034-11-19 U-2494 2024-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205108-001 9724297 2035-08-31 U-2096 Drug product 2017-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205108-001 10206895 2034-04-01 U-2096 Drug product 2019-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205108-001 10206895 2034-04-01 U-2494 Drug product 2019-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205108-001 11013703 2034-04-01 Drug product 2021-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205108-001 11850222 2034-11-19 U-2096 2024-01-05 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base SOTYLIZE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOTALOL HYDROCHLORIDE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593725 Internal RxNorm lookup 1593731 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 24338-530-25 SOTYLIZE 250 mL in 1 BOTTLE SOLUTION 250 6 24338-530-48 SOTYLIZE 480 mL in 1 BOTTLE SOLUTION 480 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-530 SOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240130_1f33f900-0777-4a92-a7f7-00cf3d57d95c.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 SOTYLIZE SOTALOL HYDROCHLORIDE Azurity Pharmaceuticals, Inc. 1f33f900-0777-4a92-a7f7-00cf3d57d95c 2024-01-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 205108 application number: NDA205108 ndc (product): 24338-530
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 24338-530-25 24338053025 250 mL in 1 BOTTLE (24338-530-25) 250 ml 2015-03-01 0000-00-00 No No Current 24338-530-48 24338053048 480 mL in 1 BOTTLE (24338-530-48) 480 ml 2015-03-01 0000-00-00 No No Current