sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-951
Product ID 82804-951_10b7b81d-9ce7-4025-8559-fdfa41c8b146
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075563
Listing Expiration 2027-12-31
Marketing Start 2020-07-24

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] antiarrhythmic [epc] cardiac rhythm alteration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804951
Hyphenated Format 82804-951

Supplemental Identifiers

RxCUI
1923422
UPC
0382804951307
UNII
HEC37C70XX

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sotalol hydrochloride (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number ANDA075563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82804-951-00)
  • 1000 TABLET in 1 BOTTLE (82804-951-11)
  • 30 TABLET in 1 BOTTLE (82804-951-30)
  • 500 TABLET in 1 BOTTLE (82804-951-55)
  • 60 TABLET in 1 BOTTLE (82804-951-60)
  • 120 TABLET in 1 BOTTLE (82804-951-72)
  • 90 TABLET in 1 BOTTLE (82804-951-90)
  • 300 TABLET in 1 BOTTLE (82804-951-96)
source: ndc

Packages (8)

82804-951-00 100 TABLET in 1 BOTTLE (82804-951-00) 82804-951-11 1000 TABLET in 1 BOTTLE (82804-951-11) 82804-951-30 30 TABLET in 1 BOTTLE (82804-951-30) 82804-951-55 500 TABLET in 1 BOTTLE (82804-951-55) 82804-951-60 60 TABLET in 1 BOTTLE (82804-951-60) 82804-951-72 120 TABLET in 1 BOTTLE (82804-951-72) 82804-951-90 90 TABLET in 1 BOTTLE (82804-951-90) 82804-951-96 300 TABLET in 1 BOTTLE (82804-951-96)

Ingredients (1)

sotalol hydrochloride (120 mg/1)

Linked Drug Pages (1)

Sotalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10b7b81d-9ce7-4025-8559-fdfa41c8b146", "openfda": {"upc": ["0382804951307"], "unii": ["HEC37C70XX"], "rxcui": ["1923422"], "spl_set_id": ["10b7b81d-9ce7-4025-8559-fdfa41c8b146"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82804-951-00)", "package_ndc": "82804-951-00", "marketing_start_date": "20260112"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82804-951-11)", "package_ndc": "82804-951-11", "marketing_start_date": "20260112"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-951-30)", "package_ndc": "82804-951-30", "marketing_start_date": "20260112"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (82804-951-55)", "package_ndc": "82804-951-55", "marketing_start_date": "20260112"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-951-60)", "package_ndc": "82804-951-60", "marketing_start_date": "20260112"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (82804-951-72)", "package_ndc": "82804-951-72", "marketing_start_date": "20260112"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-951-90)", "package_ndc": "82804-951-90", "marketing_start_date": "20260112"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (82804-951-96)", "package_ndc": "82804-951-96", "marketing_start_date": "20260112"}], "brand_name": "Sotalol Hydrochloride", "product_id": "82804-951_10b7b81d-9ce7-4025-8559-fdfa41c8b146", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "82804-951", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075563", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20271231"}