Drugplain

DARUNAVIR 600 mg/1

DARUNAVIR · TABLET, FILM COATED · Lupin Pharmaceuticals, Inc.

2 Recalls on Record
Plain English

DARUNAVIR is a tablet, film coated containing darunavir at 600 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..

Key Facts

Brand Name
DARUNAVIR
Generic Name
DARUNAVIR
NDC Code (Product)
68180-345
Manufacturer
Lupin Pharmaceuticals, Inc.
Strength
600 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA202073
Marketing Start
06/01/2023

Recall History

2 Recalls on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug interaction694 reports
foetal exposure during pregnancy494 reports
virologic failure325 reports
maternal exposure during pregnancy313 reports
drug resistance283 reports
off label use246 reports
death238 reports
drug ineffective235 reports
exposure during pregnancy226 reports
treatment failure223 reports

Frequently Asked Questions

What is DARUNAVIR used for?

DARUNAVIR contains DARUNAVIR. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is DARUNAVIR a controlled substance?

DARUNAVIR is not classified as a controlled substance by the DEA.

What is the generic name for DARUNAVIR?

The generic name for DARUNAVIR is DARUNAVIR. There are 12 other brand versions of DARUNAVIR.

What is the NDC code for DARUNAVIR 600 mg/1?

The NDC (National Drug Code) for DARUNAVIR 600 mg/1 is 68180-345, listed by Lupin Pharmaceuticals, Inc..