NDC 13913-010

Lazanda

Fentanyl Citrate

Lazanda is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Depomed, Inc.. The primary component is Fentanyl Citrate.

• Product ID: 13913-010_c2b4b455-fd85-4767-baee-4d068f08e4e7
• NDC: 13913-010
• 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: Depomed, Inc.
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 400 ug/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 13913-010-01

1 BOTTLE, SPRAY in 1 CARTON (13913-010-01) > 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 13913-010-01 [13913001001]

Lazanda SPRAY

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

NDC 13913-010-04 [13913001004]

Lazanda SPRAY

• Marketing Category: NDA
• Application Number: NDA022569
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-17
• Marketing End Date: 2015-01-12

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	400 ug/1

OpenFDA Data

• SPL SET ID: 9dcaff31-1653-11e3-8ffd-0800200c9a66
• Manufacturer:
  • Depomed, Inc.
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 1729322
  • 1729320
  • 1115579
  • 1115577
  • 1115575
  • 1115573
• UPC Code:
  • 0313913010012
  • 0313913009016
  • 0313913013013

Pharmacological Class

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