NDC 0088-2100

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: 0088-2100_303e8c3c-6971-48c8-9ed4-174d282ffe92
• NDC: 0088-2100
• Product Type: Human Prescription Drug
• Proprietary Name: Priftin
• Generic Name: Rifapentine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-03-30
• 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 0088-2100-32

4 POUCH in 1 CARTON (0088-2100-32) > 8 BLISTER PACK in 1 POUCH > 1 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2009-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0088-2100-24 [00088210024]

Priftin TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-03-30
• Marketing End Date: 2020-11-30

NDC 0088-2100-03 [00088210003]

Priftin TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-03-30
• Marketing End Date: 2018-06-28

NDC 0088-2100-32 [00088210032]

Priftin TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021024
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-03-30
• Marketing End Date: 2020-11-30

Drug Details

Active Ingredients

Ingredient	Strength
RIFAPENTINE	150 mg/1

OpenFDA Data

• SPL SET ID: f768e337-a948-420a-9fbe-9be359c7a170
• 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