NDC 71500-130

Lazanda

Fentanyl

Lazanda is a Nasal Aerosol, Spray in the Human Prescription Drug category. It is labeled and distributed by West Therapeutic Development Llc. The primary component is Fentanyl Citrate.

• Product ID: 71500-130_73f38bde-2133-2b5a-e053-2a91aa0a6efb
• NDC: 71500-130
• Product Type: Human Prescription Drug
• Proprietary Name: Lazanda
• Generic Name: Fentanyl
• Dosage Form: Aerosol, Spray
• Route of Administration: NASAL
• Marketing Start Date: 2018-08-25
• Marketing Category: NDA / NDA
• Application Number: NDA022569
• Labeler Name: West Therapeutic Development LLC
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 300 ug/81
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71500-130-01

1 BOTTLE, SPRAY in 1 CARTON (71500-130-01) > 8 SPRAY in 1 BOTTLE, SPRAY

• Marketing Start Date: 2018-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71500-130-01 [71500013001]

LAZANDA SPRAY

• Marketing Category: NDA
• Application Number: NDA022569
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-25

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	300 ug/81

OpenFDA Data

• SPL SET ID: 73f38bde-2132-2b5a-e053-2a91aa0a6efb
• Manufacturer:
  • West Therapeutic Development LLC
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 1729322
  • 1729320
  • 1115579
  • 1115577
  • 1115575
  • 1115573
• UPC Code:
  • 0371500140016
  • 0371500110019
  • 0371500130017

Pharmacological Class

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

NDC Crossover Matching brand name "Lazanda" or generic name "Fentanyl"

NDC	Brand Name	Generic Name
13913-009	Lazanda	fentanyl citrate
13913-010	Lazanda	fentanyl citrate
13913-013	Lazanda	fentanyl citrate
71500-140	Lazanda	Lazanda
71500-110	Lazanda	Lazanda
71500-130	Lazanda	Lazanda
51772-314	LAZANDA	LAZANDA
51772-311	LAZANDA	LAZANDA
0378-9119	FENTANYL	FENTANYL
0378-9121	FENTANYL	FENTANYL
0378-9122	FENTANYL	FENTANYL
0378-9123	FENTANYL	FENTANYL
0378-9124	FENTANYL	FENTANYL
0378-9125	FENTANYL	FENTANYL
0378-9126	FENTANYL	FENTANYL
0378-9127	FENTANYL	FENTANYL
0591-3198	Fentanyl	Fentanyl
0591-3212	Fentanyl	Fentanyl
0591-3213	Fentanyl	Fentanyl
0591-3214	Fentanyl	Fentanyl
0781-7240	Fentanyl	Fentanyl
0781-7241	Fentanyl	Fentanyl
0781-7242	Fentanyl	Fentanyl
0781-7243	Fentanyl	Fentanyl
0781-7244	Fentanyl	Fentanyl
20482-001	SUBSYS	fentanyl
20482-002	SUBSYS	fentanyl