NDC 42358-101

Levorphanol Tartrate

Levorphanol Tartrate

Levorphanol Tartrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sentynl Therapeutics, Inc.. The primary component is Levorphanol Tartrate.

Product ID42358-101_0213cb31-c752-4e52-8cd4-cb3e20c23649
NDC42358-101
Product TypeHuman Prescription Drug
Proprietary NameLevorphanol Tartrate
Generic NameLevorphanol Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-18
Marketing CategoryANDA / ANDA
Application NumberANDA074278
Labeler NameSentynl Therapeutics, Inc.
Substance NameLEVORPHANOL TARTRATE
Active Ingredient Strength1 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42358-101-10

100 TABLET in 1 BOTTLE, PLASTIC (42358-101-10)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42358-101-10 [42358010110]

Levorphanol Tartrate TABLET
Marketing CategoryANDA
Application NumberANDA074278
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18
Marketing End Date2018-12-03

Drug Details

Active Ingredients

IngredientStrength
LEVORPHANOL TARTRATE1 mg/1

OpenFDA Data

SPL SET ID:77f4a54a-6901-46d9-93db-ad4be7eae6c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2058845
  • 2058843
  • 197873
    • UPC Code
  • 0342358101108
  • 0342358103102
  • 0342358102105

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Levorphanol Tartrate" or generic name "Levorphanol Tartrate"

    NDCBrand NameGeneric Name
    0406-2224Levorphanol TartrateLevorphanol Tartrate
    0527-3236Levorphanol TartrateLevorphanol Tartrate
    0527-3237Levorphanol TartrateLevorphanol Tartrate
    42358-101Levorphanol TartrateLevorphanol Tartrate
    42358-102Levorphanol TartrateLevorphanol Tartrate
    42358-103Levorphanol TartrateLevorphanol Tartrate
    57664-762Levorphanol TartrateLevorphanol Tartrate
    63629-2093Levorphanol TartrateLevorphanol Tartrate
    69543-412Levorphanol TartrateLevorphanol Tartrate
    69543-417Levorphanol TartrateLevorphanol Tartrate
    70954-236Levorphanol TartrateLevorphanol Tartrate
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.