Humalog
NDC 0002-8208
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Humalog is a BLA-approved product labeled by Eli Lilly And Company. Insulin lispro is used with a proper diet and exercise program to control high blood sugar in people with diabetes. It is supplied as a product. This product entry covers the primary NDC 0002-8208 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0002-8208
Proprietary Name:
Humalog Tempo Pen
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0002
Product Label ID:
FDA Application Number: [6]
BLA205747
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
05-26-2015
End Marketing Date: [10]
05-07-2025
Listing Expiration Date: [11]
05-07-2025
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 0002-8208?
The NDC code 0002-8208 is assigned by the FDA to the product Humalog Tempo Pen. This pharmaceutical product is labeled by Eli Lilly And Company and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0002-8208-27. 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?
Insulin lispro is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin lispro is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. Insulin lispro starts working faster and lasts for a shorter time than regular insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication is usually used with a medium- or long-acting insulin product. Insulin lispro may also be used with other oral diabetes medications (such as sulfonylureas like glyburide or glipizide).
What is the NDC to RxNorm Crosswalk for this product?
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: 1652239 - insulin lispro 200 UNT/ML in 3 ML Pen Injector
- RxCUI: 1652239 - 3 ML insulin lispro 200 UNT/ML Pen Injector
- RxCUI: 1652242 - HumaLOG 200 UNT/ML in 3 ML Pen Injector
- RxCUI: 1652242 - 3 ML insulin lispro 200 UNT/ML Pen Injector [Humalog]
- RxCUI: 1652242 - 3 ML Humalog 200 UNT/ML Pen Injector
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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 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.
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".
