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  4. NDC Product Code: 68405-013 Strazepam

NDC 68405-013 Strazepam

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68405-013?
  5. Strazepam 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:
68405-013
Proprietary Name:
Strazepam
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physician Therapeutics Llc
Labeler Code:
68405
Product Label ID:
a4231f67-6c04-4ce6-8c3d-6db52afaadbe
Start Marketing Date: [9]
02-15-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - BLUE OPAQUE CAP AND WHITE OPAQUE BODY)
RED (C48326 - RED)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
21 MM
Imprint(s):
15MG;NOVEL121
;
Score:
1

Code Structure Chart

Product Details

What is NDC 68405-013?

The NDC code 68405-013 is assigned by the FDA to the product Strazepam 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 68405-013-06 1 kit in 1 kit * 60 capsule in 1 bottle * 30 capsule in 1 bottle (52959-535-30). 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 Strazepam?

INDICATIONS AND USAGE Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. INDICATIONS FOR USE Sentra PM is intended for the clinical dietary management of the metabolic processes associated with sleep disorders.

Which are Strazepam UNII Codes?

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

Which are Strazepam 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 Strazepam?

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 code indicates a single concept unique identifier (RXCUI) is 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".