NDC 70771-1356 Dutasteride And Tamsulosin Hydrochloride
Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
WHITE (C48325 - OPAQUE WHITE BODY)
Code Structure Chart
Product Details
What is NDC 70771-1356?
What are the uses for Dutasteride And Tamsulosin Hydrochloride?
What are Dutasteride And Tamsulosin Hydrochloride Active Ingredients?
- DUTASTERIDE .5 mg/1 - A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.
- TAMSULOSIN HYDROCHLORIDE .4 mg/1 - A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.
Which are Dutasteride And Tamsulosin Hydrochloride UNII Codes?
The UNII codes for the active ingredients in this product are:
- DUTASTERIDE (UNII: O0J6XJN02I)
- DUTASTERIDE (UNII: O0J6XJN02I) (Active Moiety)
- TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR)
- TAMSULOSIN (UNII: G3P28OML5I) (Active Moiety)
Which are Dutasteride And Tamsulosin Hydrochloride Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- ALCOHOL (UNII: 3K9958V90M)
- AMMONIA (UNII: 5138Q19F1X)
- BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
- CARRAGEENAN (UNII: 5C69YCD2YJ)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- GELATIN (UNII: 2G86QN327L)
- GLYCERIN (UNII: PDC6A3C0OX)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- POTASSIUM CHLORIDE (UNII: 660YQ98I10)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- SHELLAC (UNII: 46N107B71O)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIACETIN (UNII: XHX3C3X673)
What is the NDC to RxNorm Crosswalk for Dutasteride And Tamsulosin Hydrochloride?
- RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral Capsule
- RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule
Which are the Pharmacologic Classes for Dutasteride And Tamsulosin Hydrochloride?
* Please review the disclaimer below.
Patient Education
Dutasteride
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.
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Tamsulosin
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.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".