Home NDC 0093-1060 Sotalol Hydrochloride
Product NDC 0093-1060
11-digit product format 000931060
Labeler code 0093
Product ID 0093-1060_b0c7f185-187e-443c-9ca8-7ff9658bf713
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sotalol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA075429
Marketing category ANDA
Marketing start 2000-05-05
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075429-001 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 A075429-002 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 A075429-003 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 A075429-004 SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A075429-001 SOTALOL HYDROCHLORIDE 80MG TABLET / ORAL AB 2000-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A075429-002 SOTALOL HYDROCHLORIDE 120MG TABLET / ORAL AB 2000-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A075429-003 SOTALOL HYDROCHLORIDE 160MG TABLET / ORAL AB 2000-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A075429-004 SOTALOL HYDROCHLORIDE 240MG TABLET / ORAL AB 2000-05-01 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 31404462-7fa0-20d6-e063-6294a90aa58c 2025-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429 Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Proficient Rx LP 6acf10b5-bbd9-4993-99a9-2cdb8cec96c5 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429 Sotalol Hydrochloride SOTALOL HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 8e2772cb-7dea-42d1-ba31-d479ba7cb09a 2023-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075429 application number: ANDA075429 ndc (product): 0093-1060
Additional Listing Data#
Finished product Yes
Brand name base Sotalol Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOTALOL HYDROCHLORIDE 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HEC37C70XX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904589 Internal RxNorm lookup 1923422 Internal RxNorm lookup 1923424 Internal RxNorm lookup 1923426 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-1060-01 Sotalol Hydrochloride 100 in 1 BOTTLE TABLET 100 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-1060 SOTALOL HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20240126_8e2772cb-7dea-42d1-ba31-d479ba7cb09a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-1060-01 00093106001 100 TABLET in 1 BOTTLE (0093-1060-01) 100 tablet 2000-05-05 0000-00-00 No No Current