NDC 69543-412

Levorphanol Tartrate

Levorphanol Tartrate

Levorphanol Tartrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals, Llc. The primary component is Levorphanol Tartrate.

Product ID69543-412_28501185-fe1f-47e5-ace9-b1dca5b2eca0
NDC69543-412
Product TypeHuman Prescription Drug
Proprietary NameLevorphanol Tartrate
Generic NameLevorphanol Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-12-13
Marketing CategoryANDA / ANDA
Application NumberANDA211484
Labeler NameVirtus Pharmaceuticals, LLC
Substance NameLEVORPHANOL TARTRATE
Active Ingredient Strength2 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69543-412-10

100 TABLET in 1 BOTTLE (69543-412-10)
Marketing Start Date2018-12-13
Marketing End Date2024-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69543-412-10 [69543041210]

Levorphanol Tartrate TABLET
Marketing CategoryANDA
Application NumberANDA211484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

Drug Details

Active Ingredients

IngredientStrength
LEVORPHANOL TARTRATE2 mg/1

OpenFDA Data

SPL SET ID:85b9fc9e-e09f-4297-af8f-c9b338f78503
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197873
    • UPC Code
  • 0369543412108

    • 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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