NDC 0088-2102

Priftin

Rifapentine

Priftin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Rifapentine.

• Product ID: 0088-2102_001813e9-aec0-400f-9502-14376adf0b94
• NDC: 0088-2102
• Product Type: Human Prescription Drug
• Proprietary Name: Priftin
• Generic Name: Rifapentine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-08
• Marketing Category: NDA / NDA
• Application Number: NDA021024
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: RIFAPENTINE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0088-2102-24

3 BLISTER PACK in 1 CARTON (0088-2102-24) > 8 TABLET, FILM COATED in 1 BLISTER PACK (0088-2102-01)

• Marketing Start Date: 2017-02-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0088-2102-01 [00088210201]

Priftin TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-08

NDC 0088-2102-24 [00088210224]

Priftin TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-08

Drug Details

Active Ingredients

Ingredient	Strength
RIFAPENTINE	150 mg/1

OpenFDA Data

• SPL SET ID: 3a64fb70-b85e-43d9-8bcd-7e893f568ae1
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • XJM390A33U
• RxNorm Concept Unique ID - RxCUI:
  • 242671
  • 261101

Pharmacological Class

• Rifamycin Antimycobacterial [EPC]
• Rifamycins [CS]

NDC Crossover Matching brand name "Priftin" or generic name "Rifapentine"

NDC	Brand Name	Generic Name
0088-2100	Priftin	rifapentine
0088-2102	Priftin	rifapentine
50090-5063	Priftin	rifapentine