Search by Drug Name or NDC
NDC 42291-0031-30 Dutasteride and Tamsulosin Hydrochloride .5; .4 mg/1; mg/1 Details
Dutasteride and Tamsulosin Hydrochloride .5; .4 mg/1; mg/1
Dutasteride and Tamsulosin Hydrochloride is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Dutasteride may also decrease the chance that prostate surgery will be needed. Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate.
Related Packages: 42291-0031-30Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Dutasteride
Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.
Related Packages: 42291-0031-30Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Tamsulosin
Product Information
| NDC | 42291-0031 |
|---|---|
| Product ID | 42291-031_0a334eb9-cad0-f213-e063-6394a90a46da |
| Associated GPIs | |
| GCN Sequence Number | 066352 |
| GCN Sequence Number Description | dutasteride/tamsulosin HCl CPMP 24HR 0.5-0.4 MG ORAL |
| HIC3 | Q9C |
| HIC3 Description | BPH 5-ALPHA-REDUCTASE INHIB-ALPHA1-ADRENOCEP ANTAG |
| GCN | 28596 |
| HICL Sequence Number | 036984 |
| HICL Sequence Number Description | DUTASTERIDE/TAMSULOSIN HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dutasteride and Tamsulosin Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dutasteride and Tamsulosin Hydrochloride Capsules |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | .5; .4 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202509 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0031-30 (42291003130)
| NDC Package Code | 42291-031-30 |
|---|---|
| Billing NDC | 42291003130 |
| Package | 30 CAPSULE in 1 BOTTLE (42291-031-30) |
| Marketing Start Date | 2023-11-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |