Dulaglutide Injection, Solution
NDC 0002-1402
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
Dulaglutide is a DRUG FOR FURTHER PROCESSING-approved product labeled by Eli Lilly And Company. Dulaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It is supplied as a injection, solution. This product entry covers the primary NDC 0002-1402 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0002-1402
Proprietary Name:
Dulaglutide
Non-Proprietary Name: [1]
Dulaglutide
Substance Name: [2]
Dulaglutide
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Solution
- A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0002
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Marketing Timeline
Start Marketing Date: [9]
09-22-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure Chart
Product Details
What is NDC 0002-1402?
The NDC code 0002-1402 is assigned by the FDA to the product Dulaglutide. It is commonly known by its generic name, dulaglutide. This pharmaceutical product is labeled by Eli Lilly And Company and is currently categorized as listed product. The medication is a injection, solution. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0002-1402-71. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Dulaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. This medication is also used to lessen the risk of a major cardiovascular event (such as heart attack or stroke) in people who already have, or are at high risk for heart/blood vessel disease. Dulaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and by decreasing the amount of sugar your liver makes. Dulaglutide is not a substitute for insulin if you need insulin treatment.
What are Active Ingredients of this product?
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.
- DULAGLUTIDE 1.5 mg/.5mL - a glucagon-like peptide-1 receptor agonist; GLP-1 immunoglobulin G (IgG4) Fc fusion protein with extended activity
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Product & Regulatory Definitions
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.
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.
