NDC 54868-5914 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:
54868-5914
Proprietary Name:
Ropinirole Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
07-02-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
YELLOW (C48330 - YELLOW)
GREEN (C48329 - GREEN)
PINK (C48328 - PINK)
BROWN (C48332 - BROWN)
Shape:
ROUND (C48348)
Size(s):
6 MM
8 MM
Imprint(s):
COR;201
COR;202
COR;203
COR;204
COR;206
Score:
1

Product Packages

NDC Code 54868-5914-0

Package Description: 10 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 54868-5914-1

Package Description: 30 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 54868-5914-2

Package Description: 90 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Code 54868-5914-3

Package Description: 60 TABLET, COATED in 1 BOTTLE, PLASTIC

Product Details

What is NDC 54868-5914?

The NDC code 54868-5914 is assigned by the FDA to the product Ropinirole Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 54868-5914-0 10 tablet, coated in 1 bottle, plastic , 54868-5914-1 30 tablet, coated in 1 bottle, plastic , 54868-5914-2 90 tablet, coated in 1 bottle, plastic , 54868-5914-3 60 tablet, 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 contraindicated for patients known to have hypersensitivity reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.

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:

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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".