RIFAMPIN 150 mg/1
rifampin · CAPSULE · PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
RIFAMPIN is a capsule containing rifampin at 150 mg/1, taken oral. Manufactured by PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS.
Key Facts
- Brand Name
- RIFAMPIN
- Generic Name
- rifampin
- NDC Code (Product)
24658-801- Manufacturer
- PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA064150
- Drug Class
- Rifamycin Antibacterial [EPC]
- Marketing Start
- 03/14/2023
Recall History
Akorn, Inc.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Lupin Pharmaceuticals Inc.
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
RemedyRepack Inc.
Failed Impurities/Degradation specifications
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Sanofi-Synthelabo
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Lupin Pharmaceuticals Inc.
Subpotent Drug and Failed Impurities/Degradation Specifications
Amerisource Health Services LLC
Failed Impurities/Degradation Specification.
Sanofi US
Subpotent drug: low fill volume in some of the capsules
Frequently Asked Questions
What is RIFAMPIN used for?
RIFAMPIN contains rifampin. It is a capsule taken oral. Consult your doctor for specific uses.
Is RIFAMPIN a controlled substance?
RIFAMPIN is not classified as a controlled substance by the DEA.
What is the generic name for RIFAMPIN?
The generic name for RIFAMPIN is rifampin. There are 8 other brand versions of rifampin.
What is the NDC code for RIFAMPIN 150 mg/1?
The NDC (National Drug Code) for RIFAMPIN 150 mg/1 is 24658-801, listed by PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS.