NDC 0002-4491 Reyvow
Lasmiditan Tablet Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0002-4491?
    5. Reyvow Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Patient Education

Product Information

NDC Product Code0002-4491
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Reyvow
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Lasmiditan
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Lasmiditan
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Eli Lilly And Company
Labeler Code0002
SPL SET ID:aea3358c-ff41-4490-9e6d-c7bf7b3de13f
FDA Application Number 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.		NDA211280
DEA Schedule What is the Drug Enforcement Administration (DEA) CV Schedule?
The controlled substances in the CV schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the United States. Substances in schedule CV are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV schedule drug.		Schedule V (CV) Substances
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		10-11-2019
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Characteristics

Color(s)GRAY (C48324 - LIGHT GRAY)
PURPLE (C48327 - LIGHT PURPLE)
ShapeOVAL (C48345)
Size(s)9 MM
12 MM
Imprint(s)L50;4312
L100;4491
Score1

Product Packages

NDC Code 0002-4491-08

Package Description: 2 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

Price per Unit: $88.73196 per EA

NDC Code 0002-4491-61

Package Description: 1 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

NDC Code 0002-4491-62

Package Description: 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK

Product Details

What is NDC 0002-4491?

The NDC code 0002-4491 is assigned by the FDA to the product Reyvow which is a human prescription drug product labeled by Eli Lilly And Company. The generic name of Reyvow is lasmiditan. The product's dosage form is tablet and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0002-4491-08 2 blister pack in 1 carton / 4 tablet in 1 blister pack, 0002-4491-61 1 blister pack in 1 carton / 4 tablet in 1 blister pack, 0002-4491-62 1 blister pack in 1 carton / 2 tablet in 1 blister pack. 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 Reyvow?

REYVOW™ is indicated for the acute treatment of migraine with or without aura in adults.

What are Reyvow Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Reyvow UNII Codes?

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

Which are Reyvow 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 Reyvow?

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

Lasmiditan


Lasmiditan is used to treat the symptoms of migraine headaches (severe throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Lasmiditan is in a class of medications called selective serotonin receptor agonists. Lasmiditan may work by stopping pain signals from being sent to the brain and stopping inflammation of the nerves that cause symptoms of migraine. Lasmiditan does not prevent migraine attacks or reduce the number of headaches you have.
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* Please review the disclaimer below.

Product Label

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