NDC 0068-0599

Rifadin IV NOVAPLUS

Rifampin

Rifadin IV NOVAPLUS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Rifampin.

• Product ID: 0068-0599_0b052072-4d59-4847-adc9-0c9b56f11f2c
• NDC: 0068-0599
• Product Type: Human Prescription Drug
• Proprietary Name: Rifadin IV NOVAPLUS
• Generic Name: Rifampin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA050627
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: RIFAMPIN
• Active Ingredient Strength: 600 mg/10mL
• Pharm Classes: Rifamycin Antibacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0068-0599-01

1 VIAL, GLASS in 1 CARTON (0068-0599-01) > 10 mL in 1 VIAL, GLASS

• Marketing Start Date: 2017-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0068-0599-10 [00068059910]

Rifadin IV NOVAPLUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050627
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-01
• Marketing End Date: 2019-09-05

NDC 0068-0599-01 [00068059901]

Rifadin IV NOVAPLUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050627
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-01

Drug Details

Active Ingredients

Ingredient	Strength
RIFAMPIN	600 mg/10mL

OpenFDA Data

• SPL SET ID: 87839f65-cb33-412e-929e-564136501a84
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • VJT6J7R4TR
• RxNorm Concept Unique ID - RxCUI:
  • 207436
  • 312821

Pharmacological Class

• Rifamycin Antibacterial [EPC]
• Rifamycins [CS]

NDC Crossover Matching brand name "Rifadin IV NOVAPLUS" or generic name "Rifampin"

NDC	Brand Name	Generic Name
0068-0599	Rifadin IV NOVAPLUS	rifampin
0068-0508	Rifadin	rifampin
0068-0510	Rifadin	rifampin
0068-0597	Rifadin IV	rifampin
0143-9230	Rifampin	Rifampin
0185-0799	Rifampin	Rifampin