Sotalol Hydrochloride

Product NDC
50268-725
11-digit product format
502680725
Labeler code
50268
Product ID
50268-725_47fc0908-1c7a-abc6-e063-6294a90a20b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sotalol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076140
Marketing category
ANDA
Marketing start
2021-03-04
Substance
SOTALOL HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTALOL HYDROCHLORIDE120 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923422Internal RxNorm lookup
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
bcbc1624-283e-732f-e053-2995a90a8f11Available 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
50268-725-11Sotalol Hydrochloride1 in 1 BLISTER PACKTABLET13
50268-725-15Sotalol Hydrochloride50 in 1 BOXTABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-725-11EA - Each50268-725835612c6-92b8-4a46-920c-3274d87f5c4b12021-04-08
50268-725-15EA - Each50268-725fbcae383-9e0f-407a-928f-7b5250356fc112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-725SOTALOL HYDROCHLORIDE TABLET [AVPAK]2Current NDC, Legacy NDC, 2 package rows20221116_bcbc1624-283e-732f-e053-2995a90a8f11.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
ndc (product): 50268-725
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923422sotalol HCl 120 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol HCl 80 MG Oral TabletPSNbcbc1624-283e-732f-e053-2995a90a8f113
1923422sotalol hydrochloride 120 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113
1923426sotalol hydrochloride 80 MG Oral TabletSCDbcbc1624-283e-732f-e053-2995a90a8f113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-725-11502680725111 in 1 BLISTER PACKHistorical
50268-725-155026807251550 BLISTER PACK in 1 BOX (50268-725-15) / 1 TABLET in 1 BLISTER PACK (50268-725-11) 50 blister pack2021-03-040000-00-00NoNoCurrent