NDC 51772-311

LAZANDA

Fentanyl Citrate

LAZANDA is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Archimedes Pharma Us Inc.. The primary component is Fentanyl Citrate.

• Product ID: 51772-311_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51
• NDC: 51772-311
• Product Type: Human Prescription Drug
• Proprietary Name: LAZANDA
• Generic Name: Fentanyl Citrate
• Dosage Form: Spray
• Route of Administration: NASAL
• Marketing Start Date: 2011-10-17
• Marketing Category: NDA / NDA
• Application Number: NDA022569
• Labeler Name: Archimedes Pharma US Inc.
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 100 ug/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 51772-311-04

4 BOTTLE, SPRAY in 1 CARTON (51772-311-04) > 8 SPRAY in 1 BOTTLE, SPRAY

• Marketing Start Date: 2011-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51772-311-01 [51772031101]

LAZANDA SPRAY

• Marketing Category: NDA
• Application Number: NDA022569
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-17
• Inactivation Date: 2020-01-31

NDC 51772-311-04 [51772031104]

LAZANDA SPRAY

• Marketing Category: NDA
• Application Number: NDA022569
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	100 ug/1

OpenFDA Data

• SPL SET ID: 39531d0c-db12-4627-81c9-6563076b637b
• Manufacturer:
  • Archimedes Pharma US Inc.
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 1115577
  • 1115575
  • 1115573
  • 1115579

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "LAZANDA" or generic name "Fentanyl Citrate"

NDC	Brand Name	Generic Name
71500-140	Lazanda	Lazanda
71500-110	Lazanda	Lazanda
71500-130	Lazanda	Lazanda
13913-010	Lazanda	Lazanda
13913-013	Lazanda	Lazanda
13913-009	Lazanda	Lazanda
51772-314	LAZANDA	LAZANDA
51772-311	LAZANDA	LAZANDA
0093-7865	Fentanyl Citrate	Fentanyl Citrate
0093-7866	Fentanyl Citrate	Fentanyl Citrate
0093-7867	Fentanyl Citrate	Fentanyl Citrate
0093-7868	Fentanyl Citrate	Fentanyl Citrate
0093-7869	Fentanyl Citrate	Fentanyl Citrate
0093-7870	Fentanyl Citrate	Fentanyl Citrate
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE