NDC 0409-1623

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 ID: 0409-1623_695b7874-f6f9-4a28-8d0d-4d91f9ad3bd4
• NDC: 0409-1623
• Product Type: Human Prescription Drug
• Proprietary Name: Butorphanol Tartrate
• Generic Name: Butorphanol Tartrate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2005-09-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074626
• Labeler Name: Hospira, Inc.
• Substance Name: BUTORPHANOL TARTRATE
• Active Ingredient Strength: 1 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: 2020-12-31

Packaging

NDC 0409-1623-01

10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21)

• Marketing Start Date: 2005-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-1623-21 [00409162321]

Butorphanol Tartrate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074626
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-25

NDC 0409-1623-01 [00409162301]

Butorphanol Tartrate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074626
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-09-23

Drug Details

Active Ingredients

Ingredient	Strength
BUTORPHANOL TARTRATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 9822ca3f-aee2-46e5-8a96-495400e65d10
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 2L7I72RUHN
• RxNorm Concept Unique ID - RxCUI:
  • 1728351
  • 886627
  • 1728355

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"

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