NDC 0115-1438 Dutasteride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0115-1438
Proprietary Name:
Dutasteride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Impax Generics
Labeler Code:
0115
Start Marketing Date: [9]
11-20-2015
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - DULL YELLOW)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
M05
Score:
1

Product Packages

NDC Code 0115-1438-08

Package Description: 30 CAPSULE, LIQUID FILLED in 1 BOTTLE

Price per Unit: $0.18800 per EA

NDC Code 0115-1438-10

Package Description: 90 CAPSULE, LIQUID FILLED in 1 BOTTLE

Price per Unit: $0.18800 per EA

Product Details

What is NDC 0115-1438?

The NDC code 0115-1438 is assigned by the FDA to the product Dutasteride which is product labeled by Impax Generics. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0115-1438-08 30 capsule, liquid filled in 1 bottle , 0115-1438-10 90 capsule, liquid filled in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Dutasteride?

This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH. Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.

Which are Dutasteride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Dutasteride 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:

What is the NDC to RxNorm Crosswalk for Dutasteride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".