NDC 0409-1626

BUTORPHANOL TARTRATE

Butorphanol Tartrate

BUTORPHANOL TARTRATE is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Butorphanol Tartrate.

Product ID0409-1626_06870209-9da5-42ac-a9b6-0733c2e9b972
NDC0409-1626
Product TypeHuman Prescription Drug
Proprietary NameBUTORPHANOL TARTRATE
Generic NameButorphanol Tartrate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA074626
Labeler NameHospira, Inc.
Substance NameBUTORPHANOL TARTRATE
Active Ingredient Strength2 mg/mL
Pharm ClassesCompetitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-1626-01

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21)
Marketing Start Date2006-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-1626-01 [00409162601]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-17

NDC 0409-1626-09 [00409162609]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-31

NDC 0409-1626-02 [00409162602]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-20

NDC 0409-1626-21 [00409162621]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-25

NDC 0409-1626-10 [00409162610]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-31

NDC 0409-1626-42 [00409162642]

BUTORPHANOL TARTRATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-25

Drug Details

Active Ingredients

IngredientStrength
BUTORPHANOL TARTRATE2 mg/mL

OpenFDA Data

SPL SET ID:9e99d208-392d-4d35-89c8-0f2eaedda2b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1728351
  • 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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