sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: aiping pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler aiping pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
AiPing Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11788-052
Product ID 11788-052_d2c31b08-0c64-48be-aa84-aeaead306b2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075500
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

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 11788052
Hyphenated Format 11788-052

Supplemental Identifiers

RxCUI
904589 1923422 1923424 1923426
UPC
0311788051017 0311788052014
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 sotalol hydrochloride (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number ANDA075500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11788-052-01)
source: ndc

Packages (1)

11788-052-01 100 TABLET in 1 BOTTLE (11788-052-01)

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": "d2c31b08-0c64-48be-aa84-aeaead306b2a", "openfda": {"upc": ["0311788051017", "0311788052014"], "unii": ["HEC37C70XX"], "rxcui": ["904589", "1923422", "1923424", "1923426"], "spl_set_id": ["56326224-fc80-4b89-8ba3-70cb873173b4"], "manufacturer_name": ["AiPing Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (11788-052-01)", "package_ndc": "11788-052-01", "marketing_start_date": "20251101"}], "brand_name": "SOTALOL HYDROCHLORIDE", "product_id": "11788-052_d2c31b08-0c64-48be-aa84-aeaead306b2a", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "11788-052", "generic_name": "SOTALOL HYDROCHLORIDE", "labeler_name": "AiPing Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOTALOL HYDROCHLORIDE", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075500", "marketing_category": "ANDA", "marketing_start_date": "20251101", "listing_expiration_date": "20261231"}