Sotalol Hydrochloride

Product NDC
82804-974
11-digit product format
828040974
Labeler code
82804
Product ID
82804-974_959dc952-bed6-4538-a1a6-61ed10c06be4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075563
Marketing category
ANDA
Marketing start
2020-07-24
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075563-001SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07
A075563-002SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07
A075563-003SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07
A075563-004SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075563-001AB
A075563-002AB
A075563-003AB
A075563-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075563-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2003-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2003-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2003-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2003-11-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075563-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075563-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075563-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075563-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075563-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075563-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075563-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075563-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075563-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075563-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075563-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075563-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075563-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Sotalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HEC37C70XXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923426Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b534c632-3b67-4812-a045-3e582eda6de4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83083289-08f8-450a-8eff-9d912bdd64bbProduct name120200505
8b3790df-333b-074c-6570-5beaa3352b77Product name220190213
424d69b0-0855-4fff-846d-7ced5f554385Product name120150403
9ab69b37-6a2f-6dca-a9fd-3131946f16f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-974-00Sotalol Hydrochloride100 in 1 BOTTLETABLET1002
82804-974-11Sotalol Hydrochloride1000 in 1 BOTTLETABLET10002
82804-974-30Sotalol Hydrochloride30 in 1 BOTTLETABLET302
82804-974-55Sotalol Hydrochloride500 in 1 BOTTLETABLET5002
82804-974-60Sotalol Hydrochloride60 in 1 BOTTLETABLET602
82804-974-72Sotalol Hydrochloride120 in 1 BOTTLETABLET1202
82804-974-90Sotalol Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-974-00EA - Each82804-974addc8f86-8aa7-43a6-99d2-81e66dd5b73a12025-03-04
82804-974-11EA - Each82804-974f734f206-1247-4578-8d12-a2c6f881f2c112025-03-04
82804-974-30EA - Each82804-974f66c0e25-9954-4509-8564-32db81e1929612025-03-04
82804-974-55EA - Each82804-974950e9c75-8553-4186-9d95-c8eb6f6287de12025-03-04
82804-974-60EA - Each82804-974b7b03402-667c-46b7-8d13-a135b970a1cc12025-03-04
82804-974-72EA - Each82804-97414747d07-1194-41db-a0b5-b7ca2a8a9b6012025-03-04
82804-974-90EA - Each82804-9742e17334f-8eaa-4b72-9290-e5b8f39d77db12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-974SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, 7 package rows20250221_b534c632-3b67-4812-a045-3e582eda6de4.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack9a36d95c-6e93-4e57-befe-b5274f3592442026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack667fc1f2-6ccf-4373-89d8-6a064ee7509e2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP10b7b81d-9ce7-4025-8559-fdfa41c8b1462026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutionsbbeaba9f-0513-4980-bc29-7f9259a53ecc2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackd6c8f659-1c32-4431-bdb2-3211a1c810062025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e6ea445d-4d7c-4c32-83a7-e7683a56075b2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LPb534c632-3b67-4812-a045-3e582eda6de42025-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
ndc (product): 82804-974
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack0fd4afc7-dbf8-46be-9657-aa83bbb2c0262024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack89b33c45-ece8-496f-9c3a-94ebabf73b1b2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack6be8c8f2-3977-4b7f-ad45-38b3254afdab2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackf8d0daf3-5eab-44f1-9dec-40e5d9c2bbcf2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack2f13a6dd-dd77-47c8-ac5d-4a746c32dbd02023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEOxford Pharmaceuticals, LLCc8ac6351-b1e9-4dd2-82f2-5980814fda152023-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC253da1e1-022a-4175-bd7f-e7673cba07672022-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075563
application number: ANDA075563

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSNb534c632-3b67-4812-a045-3e582eda6de42
1923426sotalol hydrochloride 80 MG Oral TabletSCDb534c632-3b67-4812-a045-3e582eda6de42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-974-0082804097400100 TABLET in 1 BOTTLE (82804-974-00) 100 tablet2025-02-13NoNoCurrent
82804-974-11828040974111000 TABLET in 1 BOTTLE (82804-974-11) 1000 tablet2025-02-13NoNoCurrent
82804-974-308280409743030 TABLET in 1 BOTTLE (82804-974-30) 30 tablet2025-02-13NoNoCurrent
82804-974-5582804097455500 TABLET in 1 BOTTLE (82804-974-55) 500 tablet2025-02-13NoNoCurrent
82804-974-608280409746060 TABLET in 1 BOTTLE (82804-974-60) 60 tablet2025-02-13NoNoCurrent
82804-974-7282804097472120 TABLET in 1 BOTTLE (82804-974-72) 120 tablet2025-02-13NoNoCurrent
82804-974-908280409749090 TABLET in 1 BOTTLE (82804-974-90) 90 tablet2025-02-13NoNoCurrent