NDC 55648-516 Tamsulosin Hydrochloride

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:
55648-516
Proprietary Name:
Tamsulosin Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Limited
Labeler Code:
55648
Start Marketing Date: [9]
04-27-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE OPAQUE BODY )
GREEN (C48329 - OLIVE GREEN OPAQUE CAP)
Shape:
CAPSULE (C48336)
Size(s):
2 MM
Imprint(s):
W;516
Score:
1

Product Packages

NDC Code 55648-516-01

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 55648-516-02

Package Description: 100 CAPSULE in 1 BOTTLE

NDC Code 55648-516-03

Package Description: 500 CAPSULE in 1 BOTTLE

NDC Code 55648-516-04

Package Description: 2 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK

NDC Code 55648-516-05

Package Description: 1 BLISTER PACK in 1 CARTON / 30 CAPSULE in 1 BLISTER PACK

Product Details

What is NDC 55648-516?

The NDC code 55648-516 is assigned by the FDA to the product Tamsulosin Hydrochloride which is product labeled by Wockhardt Limited. The product's dosage form is . The product is distributed in 5 packages with assigned NDC codes 55648-516-01 30 capsule in 1 bottle , 55648-516-02 100 capsule in 1 bottle , 55648-516-03 500 capsule in 1 bottle , 55648-516-04 2 blister pack in 1 carton / 8 capsule in 1 blister pack, 55648-516-05 1 blister pack in 1 carton / 30 capsule in 1 blister pack. 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 Tamsulosin Hydrochloride?

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.

Which are Tamsulosin Hydrochloride UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Tamsulosin Hydrochloride?

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 indicates multiple concept unique identifiers (RXCUIs) are 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".