NDC 63629-8256 Rizatriptan Benzoate

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:
63629-8256
Proprietary Name:
Rizatriptan Benzoate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bryant Ranch Prepack
Labeler Code:
63629
Start Marketing Date: [9]
01-17-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
10
Score:
1
Flavor(s):
MENTHOL (C73403 - MENTHOL)

Product Packages

NDC Code 63629-8256-1

Package Description: 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

NDC Code 63629-8256-2

Package Description: 18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

Product Details

What is NDC 63629-8256?

The NDC code 63629-8256 is assigned by the FDA to the product Rizatriptan Benzoate which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 63629-8256-1 10 tablet, orally disintegrating in 1 bottle , 63629-8256-2 18 tablet, orally disintegrating 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 Rizatriptan Benzoate?

Rizatriptan Benzoate Orally Disintegrating Tablets, USP are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of Use Rizatriptan benzoate orally disintegrating tablets, USP should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks.Rizatriptan benzoate orally disintegrating tablets, USP are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].Rizatriptan benzoate orally disintegrating tablets, USP are not indicated for the prevention of migraine attacks.Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets, USP have not been established for cluster headache.

Which are Rizatriptan Benzoate UNII Codes?

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

Which are Rizatriptan Benzoate 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 Rizatriptan Benzoate?

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: 312837 - rizatriptan benzoate 10 MG Disintegrating Oral Tablet
  • RxCUI: 312837 - rizatriptan 10 MG Disintegrating Oral Tablet
  • RxCUI: 312837 - rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet

* Please review the disclaimer below.

Patient Education

Rizatriptan


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