NDC 0088-0576

Rifater

Rifampin, Isoniazid And Pyrazinamide

Rifater is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Rifampin; Isoniazid; Pyrazinamide.

• Product ID: 0088-0576_2209334f-337a-4dd3-82e4-64ffe1895ff3
• NDC: 0088-0576
• Product Type: Human Prescription Drug
• Proprietary Name: Rifater
• Generic Name: Rifampin, Isoniazid And Pyrazinamide
• Dosage Form: Tablet, Sugar Coated
• Route of Administration: ORAL
• Marketing Start Date: 1994-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA050705
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: RIFAMPIN; ISONIAZID; PYRAZINAMIDE
• Active Ingredient Strength: 120 mg/1; mg/1; mg/1
• Pharm Classes: Rifamycin Antibacterial [EPC],Rifamycins [CS],Antimycobacterial [EPC],Antimycobacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0088-0576-41

60 TABLET, SUGAR COATED in 1 BOTTLE (0088-0576-41)

• Marketing Start Date: 1994-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0088-0576-41 [00088057641]

Rifater TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA050705
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-05-31

Drug Details

Active Ingredients

Ingredient	Strength
RIFAMPIN	120 mg/1

OpenFDA Data

• SPL SET ID: 429a2f62-9fe6-4299-b314-92a9d22b1381
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • VJT6J7R4TR
  • V83O1VOZ8L
  • 2KNI5N06TI
• RxNorm Concept Unique ID - RxCUI:
  • 198384
  • 206698

Pharmacological Class

• Rifamycin Antibacterial [EPC]
• Rifamycins [CS]
• Antimycobacterial [EPC]
• Antimycobacterial [EPC]