Sotalol Hydrochloride

Product NDC
43353-616
11-digit product format
433530616
Labeler code
43353
Product ID
43353-616_c68dff8e-c8ac-4ed4-8700-a70b920554a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075563
Marketing category
ANDA
Marketing start
2003-11-07
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-616DDiscontinued by firm2026-08-10
excluded packagepackage43353-61643353-616-30DDiscontinued by firm2026-08-10
excluded packagepackage43353-61643353-616-60DDiscontinued by firm2026-08-10

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-616-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-616-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-616-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-616-60f5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-616-30EA - Each43353-6163e51e3af-e543-4cc7-bfca-f2953b96aeb312017-12-14
43353-616-60EA - Each43353-616e7fd854b-6a9e-462a-b000-e7ada951e66712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-616SOTALOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171127_28ba5f2a-ed6b-49a7-8a11-2d811ce9d946.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-616-304335306163030 TABLET in 1 BOTTLE, PLASTIC (43353-616-30) 30 tablet2010-03-100000-00-00NoNoCurrent
43353-616-604335306166090 TABLET in 1 BOTTLE, PLASTIC (43353-616-60) 90 tablet2010-03-100000-00-00NoNoCurrent