DUTASTERIDE .5 mg/1
DUTASTERIDE · CAPSULE · Banyan Pharma LLC
DUTASTERIDE is a capsule containing dutasteride at .5 mg/1, taken oral. Manufactured by Banyan Pharma LLC.
Key Facts
- Brand Name
- DUTASTERIDE
- Generic Name
- DUTASTERIDE
- NDC Code (Product)
84091-100- Manufacturer
- Banyan Pharma LLC
- Strength
- .5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204705
- Drug Class
- 5-alpha Reductase Inhibitor [EPC]
- Marketing Start
- 12/31/2025
Recall History
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
AVKARE Inc.
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Aidapak Services, LLC
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD65457_19, EXP: 5/24/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD56924_1, EXP: 5/21/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: W003257, EXP: 6/17/2014.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Lack of assurance of sterility
Aidapak Services, LLC
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD49582_13, EXP: 5/16/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD70639_13, EXP: 5/29/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD52993_22, EXP: 5/20/2014.
Frequently Asked Questions
What is DUTASTERIDE used for?
DUTASTERIDE contains DUTASTERIDE. It is a capsule taken oral. Consult your doctor for specific uses.
Is DUTASTERIDE a controlled substance?
DUTASTERIDE is not classified as a controlled substance by the DEA.
What is the generic name for DUTASTERIDE?
The generic name for DUTASTERIDE is DUTASTERIDE. There are 11 other brand versions of DUTASTERIDE.
What is the NDC code for DUTASTERIDE .5 mg/1?
The NDC (National Drug Code) for DUTASTERIDE .5 mg/1 is 84091-100, listed by Banyan Pharma LLC.