NDC 72000-120

Xenleta

Lefamulin Acetate

Xenleta is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nabriva Therapeutics Us, Inc.. The primary component is Lefamulin Acetate.

• Product ID: 72000-120_5b6f16e1-384a-469f-91fe-9586625fce50
• NDC: 72000-120
• Product Type: Human Prescription Drug
• Proprietary Name: Xenleta
• Generic Name: Lefamulin Acetate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-09-09
• Marketing Category: NDA / NDA
• Application Number: NDA211673
• Labeler Name: Nabriva Therapeutics US, Inc.
• Substance Name: LEFAMULIN ACETATE
• Active Ingredient Strength: 150 mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 72000-120-06

6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) > 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)

• Marketing Start Date: 2019-09-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72000-120-06 [72000012006]

Xenleta INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211673
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-09

NDC 72000-120-01 [72000012001]

Xenleta INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211673
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-09

Drug Details

Active Ingredients

Ingredient	Strength
LEFAMULIN ACETATE	150 mg/15mL

OpenFDA Data

• SPL SET ID: 101db63d-2fe2-48df-8506-1382d6dcd4a3
• Manufacturer:
  • Nabriva Therapeutics US, Inc.
• UNII:
  • XF417D3PSL
  • HDN0B924X4
• RxNorm Concept Unique ID - RxCUI:
  • 2198953
  • 2198966
  • 2198961
  • 2198948
• UPC Code:
  • 0372000110301
  • 0372000120065

NDC Crossover Matching brand name "Xenleta" or generic name "Lefamulin Acetate"

NDC	Brand Name	Generic Name
72000-110	Xenleta	lefamulin acetate
72000-120	Xenleta	lefamulin acetate