NDC 0173-0681

RELENZA

Zanamivir

RELENZA is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Zanamivir.

• Product ID: 0173-0681_0376527b-3759-4798-89ac-bebb7f8b7984
• NDC: 0173-0681
• Product Type: Human Prescription Drug
• Proprietary Name: RELENZA
• Generic Name: Zanamivir
• Dosage Form: Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 1999-09-22
• Marketing Category: NDA / NDA
• Application Number: NDA021036
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: ZANAMIVIR
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0173-0681-01

5 PACKAGE in 1 CARTON (0173-0681-01) > 4 POWDER in 1 PACKAGE

• Marketing Start Date: 1999-09-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0681-01 [00173068101]

RELENZA POWDER

• Marketing Category: NDA
• Application Number: NDA021036
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-09-22

NDC 0173-0681-00 [00173068100]

RELENZA POWDER

• Marketing Category: NDA
• Application Number: NDA021036
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-24
• Marketing End Date: 2012-11-08

Drug Details

Active Ingredients

Ingredient	Strength
ZANAMIVIR	5 mg/1

OpenFDA Data

• SPL SET ID: d7c3bcc3-0c0d-4068-fd80-88cf54a376ef
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • L6O3XI777I
• RxNorm Concept Unique ID - RxCUI:
  • 759471
  • 759473

Pharmacological Class

• Neuraminidase Inhibitor [EPC]
• Neuraminidase Inhibitors [MoA]

NDC Crossover Matching brand name "RELENZA" or generic name "Zanamivir"

NDC	Brand Name	Generic Name
0173-0681	RELENZA	zanamivir
68258-3030	RELENZA	zanamivir