NDC 0245-0012

Sorine

Sotalol Hydrochloride

Sorine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Inc.. The primary component is Sotalol Hydrochloride.

Product ID0245-0012_0b685684-711a-49dd-b27a-260ad9aea3e2
NDC0245-0012
Product TypeHuman Prescription Drug
Proprietary NameSorine
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA075500
Labeler NameUpsher-Smith Laboratories, Inc.
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0245-0012-01

100 BLISTER PACK in 1 CARTON (0245-0012-01) > 1 TABLET in 1 BLISTER PACK (0245-0012-89)
Marketing Start Date2011-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0012-89 [00245001289]

Sorine TABLET
Marketing CategoryANDA
Application NumberANDA075500
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-02

NDC 0245-0012-11 [00245001211]

Sorine TABLET
Marketing CategoryANDA
Application NumberANDA075500
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-02-15

NDC 0245-0012-01 [00245001201]

Sorine TABLET
Marketing CategoryANDA
Application NumberANDA075500
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-15

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:6ee6e904-a8e2-41d4-8261-67103ecfa605
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923424
  • 904605
  • 904593
  • 1923426
  • 1923422
  • 904583
  • 904571
  • 904589

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]
    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]

    NDC Crossover Matching brand name "Sorine" or generic name "Sotalol Hydrochloride"

    NDCBrand NameGeneric Name
    0245-0012SorineSotalol Hydrochloride
    0245-0013SorineSotalol Hydrochloride
    0245-0014SorineSotalol Hydrochloride
    0245-0015SorineSotalol Hydrochloride
    55154-5616SorineSorine
    10135-661SotalolSotalol Hydrochloride
    10135-662SotalolSotalol Hydrochloride
    10135-663SotalolSotalol Hydrochloride
    0093-1060Sotalol HydrochlorideSotalol Hydrochloride
    0093-1061Sotalol HydrochlorideSotalol Hydrochloride
    0093-1062Sotalol HydrochlorideSotalol Hydrochloride
    0093-1063Sotalol HydrochlorideSotalol Hydrochloride
    0185-0170sotalol hydrochloridesotalol hydrochloride
    0185-0171sotalol hydrochloridesotalol hydrochloride
    0185-0174sotalol hydrochloridesotalol hydrochloride
    0185-0177sotalol hydrochloridesotalol hydrochloride
    0378-5123Sotalol Hydrochloridesotalol hydrochloride
    0378-5124Sotalol Hydrochloridesotalol hydrochloride
    0378-5125Sotalol Hydrochloridesotalol hydrochloride
    0603-5769Sotalol HydrochlorideSotalol Hydrochloride
    0603-5770Sotalol HydrochlorideSotalol Hydrochloride
    0603-5771Sotalol HydrochlorideSotalol Hydrochloride
    0603-5772Sotalol HydrochlorideSotalol Hydrochloride
    0615-5552Sotalol HydrochlorideSotalol Hydrochloride
    0615-7888Sotalol HydrochlorideSotalol Hydrochloride
    0904-7143Sotalol HydrochlorideSotalol Hydrochloride

    Trademark Results [Sorine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SORINE
    SORINE
    76181044 2589801 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    2000-12-14
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.