Labeler Code definition

Labeler Code means the first 5 digits in the 11-digit national drug code (NDC) format that is assigned by the FDA.
View Source
Labeler Code means the four or five digit code assigned to the Manufacturer or distributor of drug products by the FDA included as the first four or five digits of the NDC number for the products Manufactured or distributed by such Person.
View Source
Labeler Code means the first five digits in the 11-digit national drug code (NDC) format that is assigned by the FDA and identifies the Manufacturer (as defined in 100.11)
View Source

Examples of Labeler Code in a sentence

  • All Product shall be sold under Drug Labeler Code of either Mist or an Affiliate thereof and in Mist or such Affiliate’s trade dress.

  • For the avoidance of doubt, such action shall include Purchaser’s obtaining a new National Drug Code number or Labeler Code, if it does not already have one.

  • Seller shall maintain with the FDA Seller’s National Drug Code number or Labeler Code for each Product as required for the manufacture and distribution of the Products until the latest expiry of lots of Products included in the Transferred Inventory.

  • This Agreement shall commence on the Effective Date, and shall remain in full force and effect until [*****] after the expiration date of the last lot of Product bearing Labeler Code 50458 (which date HCS shall communicate to PURCHASER as soon as reasonably practicable), unless earlier terminated by mutual agreement of the Parties, which shall be evidenced in writing.

  • The following sponsors have requested that FDA withdraw approval of the NADAs listed below because the products are no longer manufactured or marketed: Sponsor NADA Number Product (Drug) 21 CFR Cite Affected (Sponsor Drug Labeler Code) Elanco Animal Health, A Div.

  • With respect to the Medicaid program, Purchaser will discuss its acquisition of the Labeler Code with CMS promptly following the Closing Date.

  • As of the Closing, the Buyer will file for its own Labeler Code and Drug Product Listing with the U.S. Food and Drug Administration.

  • For purposes of this Agreement, “Monthly DDR Submission” means, with respect to each Product bearing Labeler Code 50458 and for a given month, (i) monthly AMP and (ii) monthly AMP Units as defined under Applicable Medicaid Rebate Law.

  • This Agreement is made and entered into by and between the state of North Dakota, acting through its North Dakota Department of Human Services, Medical Services Division (Department), and «Name» (Manufacturer), Labeler Code .

  • Seller will coordinate termination of its NDRA for the Labeler Code with Purchaser to ensure there is no disruption in Medicaid coverage for the Products under state Medicaid programs.


More Definitions of Labeler Code

Labeler Code has the meaning set forth in 42 CFR §423.2305.
View Source
Labeler Code means a five-digit numeric code assigned by the Food and Drug Administration, which identifies the firm that manufactures or distributes a specific drug. This code is the first segment of the National Drug Code.
View Source

Related to Labeler Code

  • QR Code means a matrix barcode that links to information about a battery model;

  • IMDG Code means the International Maritime Dangerous Goods Code, for the implementation of Chapter VII, Part A, of the International Convention for the Safety of Life at Sea, 1974 (SOLAS Convention), published by the International Maritime Organization (IMO), London;

  • JORC Code means the Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves prepared by the Joint Ore Reserves Committee of the Australasian Institute of Mining and Metallurgy, Australian Institute of Geoscientists and Minerals Council of Australia, as amended;

  • Sort code means the 6-digit code that identifies a particular bank and bank branch in the Republic of Ireland;

  • Access Code means the Railways (Access) Code 2000;