Sotalol Hydrochloride

Product NDC
0378-5123
11-digit product format
003785123
Labeler code
0378
Product ID
0378-5123_3f4eac4d-6f01-4e6a-8144-65448519efdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sotalol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077616
Marketing category
ANDA
Marketing start
2007-02-20
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-5123DDiscontinued by firm2026-08-10
excluded packagepackage0378-51230378-5123-01DDiscontinued 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 · 24 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 packagepackage0378-5123-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-5123-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-5123-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-5123-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-5123-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-5123-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-5123-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-5123-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-5123-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-5123-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-5123-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-5123-01557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077616-001SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07
A077616-002SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07
A077616-003SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077616-001AB
A077616-002AB
A077616-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2007-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2007-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077616-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2007-02-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077616-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077616-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077616-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077616-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077616-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077616-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077616-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077616-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077616-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077616-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077616-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077616-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077616-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077616-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077616-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077616-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077616-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077616-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077616-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077616-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5123-01EA - Each0378-51235432faeb-f693-4273-a316-c47a7081756912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSOTALOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]4

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEAurobindo Pharma Limited6f3145d7-f3c9-4456-a77d-d04c54f246682024-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077616
application number: ANDA077616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5123-0100378512301100 TABLET in 1 BOTTLE, PLASTIC (0378-5123-01) 100 tablet2007-02-200000-00-00NoNoCurrent