Rifater

Product NDC

0088-0576

11-digit product format

000880576

Labeler code

0088

Product ID

0088-0576_d05ae5f4-9271-4cb9-b526-be7488470625

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

rifampin, isoniazid and pyrazinamide

Dosage form

TABLET, SUGAR COATED

Route

ORAL

Labeler

sanofi-aventis U.S. LLC

Application

NDA050705

Marketing category

NDA

Marketing start

1994-05-31

Marketing end

0000-00-00

Substance

RIFAMPIN; ISONIAZID; PYRAZINAMIDE

Active strength

120 mg/1; mg/1; mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record