sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-654
Product ID 68084-654_18aceadd-5a62-1d75-e063-6394a90ab39a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076140
Listing Expiration 2026-12-31
Marketing Start 2014-03-11

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 68084654
Hyphenated Format 68084-654

Supplemental Identifiers

RxCUI
1923426
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 ANDA076140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-654-01) / 1 TABLET in 1 BLISTER PACK (68084-654-11)
source: ndc

Packages (1)

68084-654-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-654-01) / 1 TABLET in 1 BLISTER PACK (68084-654-11)

Ingredients (1)

sotalol hydrochloride (80 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": "18aceadd-5a62-1d75-e063-6394a90ab39a", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["4614480b-b36e-4dbd-9fc0-d083890d297d"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-654-01)  / 1 TABLET in 1 BLISTER PACK (68084-654-11)", "package_ndc": "68084-654-01", "marketing_start_date": "20140311"}], "brand_name": "Sotalol Hydrochloride", "product_id": "68084-654_18aceadd-5a62-1d75-e063-6394a90ab39a", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "68084-654", "generic_name": "Sotalol Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA076140", "marketing_category": "ANDA", "marketing_start_date": "20140311", "listing_expiration_date": "20261231"}