NDC 65293-009

VABOMERE

Meropenem-vaborbactam

VABOMERE is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Vaborbactam; Meropenem.

• Product ID: 65293-009_580db23f-c656-3049-e053-2a91aa0ad616
• NDC: 65293-009
• Product Type: Human Prescription Drug
• Proprietary Name: VABOMERE
• Generic Name: Meropenem-vaborbactam
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA209776
• Labeler Name: The Medicines Company
• Substance Name: VABORBACTAM; MEROPENEM
• Active Ingredient Strength: 1 g/2g; g/2g
• Pharm Classes: beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Carbapenems [CS],Penem Antibacterial [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 65293-009-06

6 VIAL, SINGLE-DOSE in 1 CARTON (65293-009-06) > 2 g in 1 VIAL, SINGLE-DOSE (65293-009-01)

• Marketing Start Date: 2017-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65293-009-01 [65293000901]

VABOMERE INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209776
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-02
• Marketing End Date: 2019-07-31

NDC 65293-009-06 [65293000906]

VABOMERE INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209776
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-02
• Marketing End Date: 2019-07-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-12

Drug Details

Active Ingredients

Ingredient	Strength
VABORBACTAM	1 g/2g

OpenFDA Data

• SPL SET ID: 580db23f-c655-3049-e053-2a91aa0ad616
• Manufacturer:
  • The Medicines Company
• UNII:
  • 1C75676F8V
  • FV9J3JU8B1
• RxNorm Concept Unique ID - RxCUI:
  • 1946651
  • 1945218

Pharmacological Class

• beta Lactamase Inhibitor [EPC]
• beta Lactamase Inhibitors [MoA]
• Carbapenems [CS]
• Penem Antibacterial [EPC]

NDC Crossover Matching brand name "VABOMERE" or generic name "Meropenem-vaborbactam"

NDC	Brand Name	Generic Name
65293-009	VABOMERE	Meropenem-Vaborbactam
70842-120	VABOMERE	Meropenem-Vaborbactam