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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065390

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NDA 065390 describes RIFAMPIN, which is a drug marketed by Chartwell Molecular, Epic Pharma Llc, Hikma, Lupin Pharms, Avet Lifesciences, Fresenius Kabi Usa, Hikma Pharms, Mylan Labs Ltd, Watson Pharms Teva, and Hikma Intl Pharms, and is included in twelve NDAs. It is available from twelve suppliers. Additional details are available on the RIFAMPIN profile page.

The generic ingredient in RIFAMPIN is isoniazid; rifampin. There are five drug master file entries for this compound. Additional details are available on the isoniazid; rifampin profile page.

Summary for 065390

Tradename:	RIFAMPIN
Applicant:	Chartwell Molecular
Ingredient:	rifampin
Patents:	0

Pharmacology for NDA: 065390

Medical Subject Heading (MeSH) Categories for 065390

Antibiotics, Antitubercular
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 065390

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIFAMPIN	rifampin	CAPSULE;ORAL	065390	ANDA	Chartwell RX, LLC	62135-315	62135-315-30	30 CAPSULE in 1 BOTTLE (62135-315-30)
RIFAMPIN	rifampin	CAPSULE;ORAL	065390	ANDA	Chartwell RX, LLC	62135-316	62135-316-60	60 CAPSULE in 1 BOTTLE (62135-316-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Mar 28, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Mar 28, 2008	TE:	AB	RLD:	No

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