Sotalol Hydrochloride

Product NDC
63187-804
11-digit product format
631870804
Labeler code
63187
Product ID
63187-804_77e00163-ec11-4bba-b1f9-08313bf22310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076140
Marketing category
ANDA
Marketing start
2003-02-01
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
A076140-001SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26
A076140-002SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26
A076140-003SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26
A076140-004SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076140-001AB
A076140-002AB
A076140-003AB
A076140-004AB

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 UTC2026-02A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076140-001SOTALOL HYDROCHLORIDE80MGTABLET / ORALAB2002-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-002SOTALOL HYDROCHLORIDE120MGTABLET / ORALAB2002-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-003SOTALOL HYDROCHLORIDE160MGTABLET / ORALAB2002-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-004SOTALOL HYDROCHLORIDE240MGTABLET / ORALAB2002-09-26d06236e962d9…

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 UTC2026-02A076140-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076140-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076140-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076140-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076140-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076140-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076140-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076140-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076140-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076140-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076140-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076140-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076140-004AB1d06236e962d9…

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
517824b1-11be-40a9-9066-d1a6a32a2938Available 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
63187-804-30Sotalol Hydrochloride30 in 1 BOTTLETABLET305
63187-804-60Sotalol Hydrochloride60 in 1 BOTTLETABLET605
63187-804-90Sotalol Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-804-30EA - Each63187-8041bcc310d-edaf-486a-89f3-acff81dcd87212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-804SOTALOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230714_517824b1-11be-40a9-9066-d1a6a32a2938.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 HYDROCHLORIDEAmerican Health Packaging4614480b-b36e-4dbd-9fc0-d083890d297d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAvPAKbcbc1624-283e-732f-e053-2995a90a8f112026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDENorthwind Health Company, LLCfe82c866-03d4-e07b-e053-6394a90a8b1e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEMajor Pharmaceuticals866e5717-3de2-4f19-b7c7-2275caeef78b2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDECardinal Health 107, LLC4f5902e1-9f9f-4c6b-817d-2efbb5e280612025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackbc35a3e8-681c-4fe8-96cd-b2a62f024c4b2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack27c73b70-99e8-40e8-8aa9-36d3addd3bb42025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack876214ba-59c4-4acc-a8ad-c6bc91837de82025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEGolden State Medical Supply, Inc.6674d53a-7137-4822-8841-4982f702a1b82025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEApotex Corp.1a56c82e-7ecd-43b0-2899-f89e47adf7db2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1f2ee505-eb90-885d-e063-6394a90a46a12024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutions7cb4879f-31e7-4862-bc0c-d439e592d81c2023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5e005309-4eca-4536-8743-c6ed9e5b31952023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP517824b1-11be-40a9-9066-d1a6a32a29382023-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076140
application number: ANDA076140
ndc (product): 63187-804

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923426sotalol HCl 80 MG Oral TabletPSN517824b1-11be-40a9-9066-d1a6a32a29385
1923426sotalol hydrochloride 80 MG Oral TabletSCD517824b1-11be-40a9-9066-d1a6a32a29385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-804-306318708043030 TABLET in 1 BOTTLE (63187-804-30) 30 tablet2017-01-020000-00-00NoNoCurrent
63187-804-606318708046060 TABLET in 1 BOTTLE (63187-804-60) 60 tablet2017-01-020000-00-00NoNoCurrent
63187-804-906318708049090 TABLET in 1 BOTTLE (63187-804-90) 90 tablet2017-01-020000-00-00NoNoCurrent