NDC 52118-002

Vibativ

Telavancin Hydrochloride

Vibativ is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Theravance, Inc.. The primary component is Telavancin Hydrochloride.

• Product ID: 52118-002_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f
• NDC: 52118-002
• Product Type: Human Prescription Drug
• Proprietary Name: Vibativ
• Generic Name: Telavancin Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-11-05
• Marketing Category: NDA / NDA
• Application Number: NDA022110
• Labeler Name: Theravance, Inc.
• Substance Name: TELAVANCIN HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/mL
• Pharm Classes: Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 52118-002-01

1 VIAL, SINGLE-USE in 1 CONTAINER (52118-002-01) > 17 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-11-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52118-002-01 [52118000201]

Vibativ INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022110
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-05
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TELAVANCIN HYDROCHLORIDE	15 mg/mL

OpenFDA Data

• SPL SET ID: 9fc67b76-9ba1-45ec-9749-ca3f3a6477d9
• Manufacturer:
  • Theravance, Inc.
• UNII:
  • 0701472ZG0
• RxNorm Concept Unique ID - RxCUI:
  • 1728089
  • 1728082
  • 1728085
  • 1728087

Pharmacological Class

• Lipoglycopeptide Antibacterial [EPC]
• Lipoglycopeptides [EXT]

NDC Crossover Matching brand name "Vibativ" or generic name "Telavancin Hydrochloride"

NDC	Brand Name	Generic Name
52118-001	Vibativ	telavancin hydrochloride
52118-002	Vibativ	telavancin hydrochloride
62847-001	Vibativ	telavancin hydrochloride
62847-002	Vibativ	telavancin hydrochloride
66220-315	VIBATIV	telavancin hydrochloride