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.
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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.
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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)
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Examples of Labeler Code in a sentence

  • The term manufacturer or importer means the per- son identified in the Labeler Code of the National Drug Code (NDC) for a branded prescription drug.(j) NDC.

  • DOD will determine branded prescription drug sales to DOD (for DOD programs other than the TRICARE retail pharmacy program) by providing, by Labeler Code, the manufacturer’s name, the NDC, brand name, and the amount paid (net of rebates and or refunds) for each branded prescription drug procured by DOD (for DOD programs other than the TRICARE retail pharmacy program) during the sales year.

  • If a distributor does not elect to submit drug listing informa- tion directly to FDA and to obtain a Labeler Code, the registered establish- ment shall submit the drug listing in- formation.

  • The Labeler Code is the first five nu- meric characters of the NDC or the first six numeric characters when the available five-character code combina- tions are exhausted.(k) Orphan drugs—(1) In general.

  • FDA will expand the Labeler Code from five to six nu- meric characters when the available five-character code combinations are exhausted.

  • The first 5 numeric characters of the 10-character code identify the man- ufacturer or distributor and are known as the Labeler Code.

  • FDA will assign Labeler Code numbers and provide them to the registrant along with the validated copy of Form FDA–2656.

  • A manufacturer or distributor with a given Labeler Code shall use only one such Product-Package Code configuration and shall use this same configuration in assigning the Product- Package Codes for all drugs included in the drug listing.

  • Then go back to the Home screen, and complete a Labeler Code Request submission - it should be pretty straightforward.

  • Create a new Labeler Code Request (select “Complete New Version” from the top of the screen once you open the one you have already submitted) - add your labeler code to the box where is goes.


More Definitions of Labeler Code

Labeler Code has the meaning set forth in 42 CFR §423.2305.
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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.
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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;

  • IBC Code means Insolvency and Bankruptcy Code, 2016 as amended from time to time;

  • STCW Code means the Seafarers’ Training, Certification and Watchkeeping Code as adopted by resolution 2 of the 1995 Conference of Parties to the STCW Convention, in its up-to-date version;

  • 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;

  • SIC code means “Standard Industrial Classification code,” as assigned to a site by the United States Department of Transportation, Federal Highway Administration, based on the particular activities that occur on the site, as set forth in its publication “Standard Industrial Classification Manual,” incorporated by reference in Section 720.111(a).

  • Polar Code means the International Code for ships operating in polar waters, consisting of an introduction, part I-A and part II-A and parts I-B and II-B, as adopted by resolutions MSC.385(94) and MEPC.264(68), as may be amended, provided that:.1 amendments to the environment-related provisions of the introduction and chapter 4 of part II-A of the Polar Code are adopted, brought into force and take effect in accordance with the provisions of article 16 of the present Convention concerning the amendment procedures applicable to an appendix to an annex; and.2 amendments to part II-B of the Polar Code are adopted by the Marine Environment Protection Committee in accordance with its Rules of Procedure.

  • Executable Code means the fully compiled version of a software program that can be executed by a computer and used by an end user without further compilation.

  • Uniform Network Code means the uniform network code as defined in Standard Special Condition A11(6) of National Grid’s transporters licence, as such code may be amended from time to time in accordance with the terms thereof.

  • Grid Code / “IEGC” or “State Grid Code” shall mean the Grid Code specified by the Central Commission under clause (h) of sub-section (1) of Section 79 of the Electricity Act and/or the State Grid Code as specified by the concerned State Commission referred under clause (h) of sub-section (1) of Section 86 of the Electricity Act, as applicable;

  • Erasmus Code A unique identifier that every higher education institution that has been awarded with the Erasmus Charter for Higher Education receives. It is only applicable to higher education institutions located in Programme Countries. 5 Country code: ISO 3166-2 country codes available at: xxxxx://xxx.xxx.xxx/obp/ui/#search. 6 Any Programme Country enterprise or, more generally, any public or private organisation active in the labour market or in the fields of education, training and youth (training of staff members from Programme Country HEIs in Partner Country non-academic partners is not eligible).

  • Tyler Software means our proprietary software, including any integrations, custom modifications, and/or other related interfaces identified in the Investment Summary and licensed by us to you through this Agreement. • “we”, “us”, “our” and similar terms mean Xxxxx. • “you” and similar terms mean Client.

  • Disabling Code means any virus, back door, timer or other limiting routine, instruction or design, or other malicious, illicit or similar unrequested code that may have the consequence (whether by design or unintentionally) of disrupting, disabling, harming, circumventing security controls or otherwise impeding in any manner the normal operation or performance of (i) any software or service or (ii) any UNICEF information system or network.

  • Access Codes means the unique codes which the Client will determine to enable his/her access to the trading platform of the Company and/or to his/her Trading Account through the Company’s electronic systems.

  • Network Code means the document now known as the Network Code and formerly known as the Railtrack Track Access Conditions 1995;

  • Uniform Code means the New York State Uniform Fire Prevention and Building Code, as currently in effect and as hereafter amended from time to time.

  • Object Code means computer software that is substantially or entirely in binary form and that is intended to be directly executable by a computer after suitable processing and linking but without any intervening steps of compilation or assembly.

  • Open Source Code means a software program that is licensed under terms that require disclosure to parties other than the licensor of the source materials of the software program or modifications thereof, or any source materials of any other software program with which the Open Source Code software program is intended to operate, or that create obligations to distribute any portions of any software program with which the Open Source Code software program is used. Open Source Code includes, without limitation, any software licensed under the GNU General Public License.

  • Privacy Act means the Privacy Act 1988 (Cth).

  • Code means the Internal Revenue Code of 1986, as amended.

  • Proprietary Software means computer software developed for and owned by the Failed Bank for its own purpose and use.

  • Applicable Data Protection Law means all data privacy or data protection laws or regulations globally that apply to the Processing of Personal Information under this Data Processing Agreement, which may include Applicable European Data Protection Law.