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  4. NDC Product Code: 42043-131 Naratriptan

NDC 42043-131 Naratriptan

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 42043-131?
  5. Naratriptan Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
42043-131
Proprietary Name:
Naratriptan
Product Type: [3]
Labeler Name: [5]
Orchidpharma, Inc
Labeler Code:
42043
Product Label ID:
ec5b909e-3406-4154-90aa-19b996e632a8
FDA Application Number: [6]
ANDA091441
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
12-12-2012
End Marketing Date: [10]
03-31-2024
Listing Expiration Date: [11]
03-31-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
GREEN (C48329)
Shape:
CAPSULE (C48336)
Size(s):
13 MM
Imprint(s):
N;1
N;2;5
Score:
1

Code Structure Chart

Product Details

What is NDC 42043-131?

The NDC code 42043-131 is assigned by the FDA to the product Naratriptan which is product labeled by Orchidpharma, Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 42043-131-09 1 blister pack in 1 carton / 9 tablet, film coated in 1 blister pack (42043-131-00). 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 Naratriptan?

Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks.Naratriptan tablets are not indicated for the prevention of migraine attacks.Safety and effectiveness of naratriptan tablets have not been established for cluster headache.

Which are Naratriptan UNII Codes?

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

Which are Naratriptan 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 Naratriptan?

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:

* Please review the disclaimer below.

Patient Education

Naratriptan


Naratriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light). Naratriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and stopping the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Naratriptan does not prevent migraine attacks or reduce the number of headaches you have.
[Learn More]


* 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".