sotalol hydrochloride af

Generic: sotalol hydrochloride tablets af

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride af
Generic Name sotalol hydrochloride tablets af
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 160 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-127
Product ID 76385-127_fe9ac463-547d-4917-a98e-61f1c0fe38f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207429
Listing Expiration 2027-12-31
Marketing Start 2020-02-21

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 76385127
Hyphenated Format 76385-127

Supplemental Identifiers

RxCUI
1922720 1922763 1922765 1923422 1923424 1923426
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 af (source: ndc)
Generic Name sotalol hydrochloride tablets af (source: ndc)
Application Number ANDA207429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (76385-127-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50)
source: ndc

Packages (2)

76385-127-01 100 TABLET in 1 BOTTLE, PLASTIC (76385-127-01) 76385-127-50 500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50)

Ingredients (1)

sotalol hydrochloride (160 mg/1)

Linked Drug Pages (1)

Sotalol, Sotalol Hydrochloride AF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe9ac463-547d-4917-a98e-61f1c0fe38f1", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922763", "1922765", "1923422", "1923424", "1923426"], "spl_set_id": ["56879738-8662-4f5c-8386-761ab2b5e46f"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76385-127-01)", "package_ndc": "76385-127-01", "marketing_start_date": "20200221"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (76385-127-50)", "package_ndc": "76385-127-50", "marketing_start_date": "20200221"}], "brand_name": "Sotalol Hydrochloride AF", "product_id": "76385-127_fe9ac463-547d-4917-a98e-61f1c0fe38f1", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "76385-127", "generic_name": "Sotalol Hydrochloride Tablets AF", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "brand_name_suffix": "AF", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "160 mg/1"}], "application_number": "ANDA207429", "marketing_category": "ANDA", "marketing_start_date": "20200221", "listing_expiration_date": "20271231"}