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  4. NDC Product Code: 54868-0106 Coregcr CR

NDC 54868-0106 Coregcr CR

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-0106?
  5. Coregcr CR Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-0106
Proprietary Name:
Coregcr CR
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4
Start Marketing Date: [9]
08-25-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
GREEN (C48329)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
16 MM
Imprint(s):
GSK;COREG;CR;10;MG
GSK;COREG;CR;20;MG
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-0106?

The NDC code 54868-0106 is assigned by the FDA to the product Coregcr CR which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 54868-0106-1 30 capsule, extended release in 1 bottle , 54868-0106-2 90 capsule, extended release 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 Coregcr CR?

COREG CR is contraindicated in the following conditions:Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol.Second- or third-degree AV blockSick sinus syndromeSevere bradycardia (unless a permanent pacemaker is in place)Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating COREG CR.Patients with severe hepatic impairmentPatients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG CR.

Which are Coregcr CR UNII Codes?

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

Which are Coregcr CR 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 Coregcr CR?

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:
  • RxCUI: 860510 - carvedilol phosphate 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860510 - 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule
  • RxCUI: 860510 - carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 860512 - COREG CR 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860512 - 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg]

* Please review the disclaimer below.

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".