betapace

Generic: sotalol hydrochloride

Labeler: legacy pharma usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name betapace
Generic Name sotalol hydrochloride
Labeler legacy pharma usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 160 mg/1

Manufacturer
Legacy Pharma USA, Inc.

Identifiers & Regulatory

Product NDC 83107-007
Product ID 83107-007_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019865
Listing Expiration 2026-12-31
Marketing Start 2016-09-01

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 83107007
Hyphenated Format 83107-007

Supplemental Identifiers

RxCUI
1922720 1922721 1922763 1922764 1922765 1922766 1923422 1923423 1923424 1923425 1923426 1923427
UPC
0383107008606 0383107009603 0383107006107 0383107007104 0383107010609 0383107005100
UNII
HEC37C70XX

Packaging Origin

Original Packager
true

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 betapace (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number NDA019865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (83107-007-10)
source: ndc

Packages (1)

83107-007-10 100 TABLET in 1 BOTTLE (83107-007-10)

Ingredients (1)

sotalol hydrochloride (160 mg/1)

Linked Drug Pages (1)

BETAPACE, BETAPACE AF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e", "openfda": {"upc": ["0383107008606", "0383107009603", "0383107006107", "0383107007104", "0383107010609", "0383107005100"], "unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922721", "1922763", "1922764", "1922765", "1922766", "1923422", "1923423", "1923424", "1923425", "1923426", "1923427"], "spl_set_id": ["a6a7702f-36c9-45db-b640-453dc324baee"], "manufacturer_name": ["Legacy Pharma USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (83107-007-10)", "package_ndc": "83107-007-10", "marketing_start_date": "20160901"}], "brand_name": "BETAPACE", "product_id": "83107-007_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "83107-007", "generic_name": "sotalol hydrochloride", "labeler_name": "Legacy Pharma USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETAPACE", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "160 mg/1"}], "application_number": "NDA019865", "marketing_category": "NDA", "marketing_start_date": "20160901", "listing_expiration_date": "20261231"}