NDC 42358-103

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 ID42358-103_0213cb31-c752-4e52-8cd4-cb3e20c23649
NDC42358-103
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 Strength3 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42358-103-10

100 TABLET in 1 BOTTLE, PLASTIC (42358-103-10)
Marketing Start Date2018-06-18
Marketing End Date2023-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42358-103-10 [42358010310]

Levorphanol Tartrate TABLET
Marketing CategoryANDA
Application NumberANDA074278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-18

Drug Details

Active Ingredients

IngredientStrength
LEVORPHANOL TARTRATE3 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
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