NDC 0378-9639

Butorphanol Tartrate

Butorphanol Tartrate

Butorphanol Tartrate is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Butorphanol Tartrate.

Product ID0378-9639_00e707ab-8ab2-4ef4-9d80-ecdd3e474b56
NDC0378-9639
Product TypeHuman Prescription Drug
Proprietary NameButorphanol Tartrate
Generic NameButorphanol Tartrate
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2011-01-21
Marketing CategoryANDA / ANDA
Application NumberANDA075759
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUTORPHANOL TARTRATE
Active Ingredient Strength10 mg/mL
Pharm ClassesCompetitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-9639-43

2.5 mL in 1 VIAL, MULTI-DOSE (0378-9639-43)
Marketing Start Date2011-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9639-43 [00378963943]

Butorphanol Tartrate SPRAY
Marketing CategoryANDA
Application NumberANDA075759
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-01-21

Drug Details

Active Ingredients

IngredientStrength
BUTORPHANOL TARTRATE10 mg/mL

OpenFDA Data

SPL SET ID:9c069ce5-ea67-4f42-afe4-30b01b4ce24d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 886634
  • Pharmacological Class

    • Competitive Opioid Antagonists [MoA]
    • Opioid Agonist/Antagonist [EPC]
    • Partial Opioid Agonists [MoA]

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

    NDCBrand NameGeneric Name
    0054-3090Butorphanol TartrateButorphanol Tartrate
    0143-9864Butorphanol TartrateButorphanol Tartrate
    0143-9867Butorphanol TartrateButorphanol Tartrate
    0378-9639Butorphanol Tartratebutorphanol tartrate
    0409-1623Butorphanol TartrateButorphanol Tartrate
    0409-1626BUTORPHANOL TARTRATEbutorphanol tartrate
    60505-0813Butorphanol TartrateButorphanol Tartrate

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