NDC 70842-102

Baxdela

Delafloxacin Meglumine

Baxdela is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Melinta Therapeutics, Llc. The primary component is Delafloxacin Meglumine.

• Product ID: 70842-102_1fbc1d58-acc9-496d-b4b1-898da783df93
• NDC: 70842-102
• Product Type: Human Prescription Drug
• Proprietary Name: Baxdela
• Generic Name: Delafloxacin Meglumine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-06-19
• Marketing Category: NDA / NDA
• Application Number: NDA208611
• Labeler Name: Melinta Therapeutics, LLC
• Substance Name: DELAFLOXACIN MEGLUMINE
• Active Ingredient Strength: 300 mg/10.5mL
• Pharm Classes: Fluoroquinolone Antibacterial [EPC],Fluoroquinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70842-102-03

10 VIAL, GLASS in 1 CARTON (70842-102-03) > 10.5 mL in 1 VIAL, GLASS (70842-102-01)

• Marketing Start Date: 2017-06-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70842-102-03 [70842010203]

Baxdela INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208611
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-19

NDC 70842-102-01 [70842010201]

Baxdela INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208611
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-09

Drug Details

Active Ingredients

Ingredient	Strength
DELAFLOXACIN MEGLUMINE	300 mg/10.5mL

OpenFDA Data

• SPL SET ID: fb77637a-88d9-4aea-958f-e270030ce30d
• Manufacturer:
  • Melinta Therapeutics, Inc
• UNII:
  • N7V53U4U4T
• RxNorm Concept Unique ID - RxCUI:
  • 1927667
  • 1927682
  • 1927672
  • 1927677

Pharmacological Class

• Fluoroquinolone Antibacterial [EPC]
• Fluoroquinolones [CS]

NDC Crossover Matching brand name "Baxdela" or generic name "Delafloxacin Meglumine"

NDC	Brand Name	Generic Name
70842-101	Baxdela	delafloxacin meglumine
70842-102	Baxdela	delafloxacin meglumine