NDC 43353-198 Ropinirole 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:
43353-198
Proprietary Name:
Ropinirole Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code:
43353
Start Marketing Date: [9]
09-20-2011
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
YELLOW (C48330 - YELLOW)
GREEN (C48329 - GREEN)
PINK (C48328 - PINK)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
972;HH
973;HH
974;HH
975;HH
Score:
1

Product Packages

NDC Code 43353-198-09

Package Description: 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Product Details

What is NDC 43353-198?

The NDC code 43353-198 is assigned by the FDA to the product Ropinirole Hydrochloride which is product labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 43353-198-09 9000 tablet, film coated in 1 bottle, plastic . 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 Ropinirole Hydrochloride?

Ropinirole hydrochloride tablets are indicated for the treatment of Parkinson's disease.

Which are Ropinirole Hydrochloride UNII Codes?

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

Which are Ropinirole 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:

What is the NDC to RxNorm Crosswalk for Ropinirole 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:

* Please review the disclaimer below.

Patient Education

Ropinirole


Ropinirole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Ropinirole is also used to treat restless legs syndrome (RLS or Ekbom syndrome; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Ropinirole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
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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".