NDC 54868-1334 Carbidopa And Levodopa

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:
54868-1334
Proprietary Name:
Carbidopa And Levodopa
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]
12-09-1994
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - MOTTLED-BLUE)
YELLOW (C48330 - MOTTLED-YELLOW)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
93;292
93;293;TEVA
Score:
2

Product Packages

NDC Code 54868-1334-1

Package Description: 30 TABLET in 1 BOTTLE

NDC Code 54868-1334-2

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 54868-1334-4

Package Description: 60 TABLET in 1 BOTTLE

NDC Code 54868-1334-5

Package Description: 50 TABLET in 1 BOTTLE

NDC Code 54868-1334-6

Package Description: 90 TABLET in 1 BOTTLE

NDC Code 54868-1334-7

Package Description: 120 TABLET in 1 BOTTLE

Product Details

What is NDC 54868-1334?

The NDC code 54868-1334 is assigned by the FDA to the product Carbidopa And Levodopa which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 54868-1334-1 30 tablet in 1 bottle , 54868-1334-2 100 tablet in 1 bottle , 54868-1334-4 60 tablet in 1 bottle , 54868-1334-5 50 tablet in 1 bottle , 54868-1334-6 90 tablet in 1 bottle , 54868-1334-7 120 tablet 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 Carbidopa And Levodopa?

Carbidopa and levodopa tablets are indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. This product is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).In some patients a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy.Although the administration of carbidopa permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.Certain patients who responded poorly to levodopa have improved when carbidopa and levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes.In considering whether to give this combination product to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.

Which are Carbidopa And Levodopa UNII Codes?

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

Which are Carbidopa And Levodopa 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 Carbidopa And Levodopa?

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: 197443 - carbidopa 10 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197443 - carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197443 - Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet
  • RxCUI: 197444 - carbidopa 25 MG / levodopa 100 MG Oral Tablet
  • RxCUI: 197444 - carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet

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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".