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  4. NDC Product Code: 68405-054 Gabavale-5

NDC 68405-054 Gabavale-5

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68405-054?
  5. Gabavale-5 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:
68405-054
Proprietary Name:
Gabavale-5
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physician Therapeutics Llc
Labeler Code:
68405
Product Label ID:
188b8a95-3db7-4a6a-bddf-48b83a0c8e38
Start Marketing Date: [9]
05-07-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
BLUE (C48333 - BLUE WHITE)
Shape:
ROUND (C48348)
CAPSULE (C48336)
Size(s):
8 MM
20 MM
Imprint(s):
3926;TEVA
;
Score:
2
1

Code Structure Chart

Product Details

What is NDC 68405-054?

The NDC code 68405-054 is assigned by the FDA to the product Gabavale-5 which is product labeled by Physician Therapeutics Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68405-054-26 1 kit in 1 kit * 60 capsule in 1 bottle * 30 tablet in 1 bottle (52959-047-30). 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 Gabavale-5?

INDICATIONSDiazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. INDICATIONS FOR USEGABAdone is intended for the clinical dietary management of the metabolic processes in patients with sleep disorders and sleep disorders associated with anxiety.- Insomnia- Sleep maintenance insomnia- Sleep disorders of circadian origin- Sleep disorders associated with anxiety- Snoring

Which are Gabavale-5 UNII Codes?

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

Which are Gabavale-5 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 Gabavale-5?

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".