NDC 0068-0509

Rifamate

Rifampin And Isoniazid

Rifamate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Rifampin; Isoniazid.

• Product ID: 0068-0509_1e0a48bf-ad7b-454b-aea6-82ae1b841302
• NDC: 0068-0509
• Product Type: Human Prescription Drug
• Proprietary Name: Rifamate
• Generic Name: Rifampin And Isoniazid
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1975-07-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA061884
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: RIFAMPIN; ISONIAZID
• Active Ingredient Strength: 300 mg/1; mg/1
• Pharm Classes: Rifamycin Antibacterial [EPC],Rifamycins [CS],Antimycobacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0068-0509-60

60 CAPSULE in 1 BOTTLE (0068-0509-60)

• Marketing Start Date: 1975-07-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0068-0509-60 [00068050960]

Rifamate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA061884
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1975-07-11

Drug Details

Active Ingredients

Ingredient	Strength
RIFAMPIN	300 mg/1

OpenFDA Data

• SPL SET ID: 3cc36609-8e2d-4caa-a8e0-c0367e3e52df
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • VJT6J7R4TR
  • V83O1VOZ8L
• RxNorm Concept Unique ID - RxCUI:
  • 198203
  • 206702
• UPC Code:
  • 0300680509603

Pharmacological Class

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

NDC Crossover Matching brand name "Rifamate" or generic name "Rifampin And Isoniazid"

NDC	Brand Name	Generic Name
0068-0509	Rifamate	rifampin and isoniazid
61748-017	IsonaRif	Rifampin and Isoniazid