NDC 60505-0813

Butorphanol Tartrate

Butorphanol Tartrate

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

• Product ID: 60505-0813_0516b370-b95c-6219-0ab1-a02732724e3c
• NDC: 60505-0813
• Product Type: Human Prescription Drug
• Proprietary Name: Butorphanol Tartrate
• Generic Name: Butorphanol Tartrate
• Dosage Form: Spray
• Route of Administration: NASAL
• Marketing Start Date: 2002-12-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075499
• Labeler Name: Apotex Corp.
• Substance Name: BUTORPHANOL TARTRATE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 60505-0813-1

1 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) > 2.5 mL in 1 BOTTLE, SPRAY

• Marketing Start Date: 2002-12-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60505-0813-1 [60505081301]

Butorphanol Tartrate SPRAY

• Marketing Category: ANDA
• Application Number: ANDA075499
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-12-04

Drug Details

Active Ingredients

Ingredient	Strength
BUTORPHANOL TARTRATE	10 mg/mL

OpenFDA Data

• SPL SET ID: b8e48063-0b40-ee43-85c1-4ef2de80c404
• Manufacturer:
  • Apotex Corp.
• UNII:
  • 2L7I72RUHN
• RxNorm Concept Unique ID - RxCUI:
  • 886634

Pharmacological Class

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

Medicade Reported Pricing

60505081301 BUTORPHANOL 10 MG/ML SPRAY

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
0054-3090	Butorphanol Tartrate	Butorphanol Tartrate
0143-9864	Butorphanol Tartrate	Butorphanol Tartrate
0143-9867	Butorphanol Tartrate	Butorphanol Tartrate
0378-9639	Butorphanol Tartrate	butorphanol tartrate
0409-1623	Butorphanol Tartrate	Butorphanol Tartrate
0409-1626	BUTORPHANOL TARTRATE	butorphanol tartrate
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate