National Drug Code (NDC) Coding

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1.0 Purpose 
 
 This procedure describes assignment and listing of a National Drug Product (NDC) code for
 
 Jon manufactured over-the-counter product. The NDC, or National Drug Code, is a unique 10
 
 digit or 11 digit, 3-segment number, and a universal identifier for human drugs in the United
 States. The Drug Listing Act of 1972 requires registered drug establishments to provide the
 
 Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared,
 propagated, compounded, or processed by it for commercial distribution. 21 CFR 207.35
 
 defines the requirements of the foreign and domestic registration and listing for Human Drugs.
 
 Product and Facilities must also be registered with the State of Florida Department of Business
 and Professional Regulation. 
 
 2.0 Scope 
 
 This procedure is applicable for all over-the-counter (OTC) Ion manufactured product. All Ion
 
 manufactured OTC product produced for commercial distribution will be assigned a unique
 
 NDC number. All NDC submissions shall be established in the Structured Product Labeling
 format for OTC drugs. Ion as a contract manufacturer may only assign Ion’s labeler code NDC
 
 listing number to Ion manufactured and distributed product. 
 
 3.0 Responsibility 
 
 3.1 The QA department is responsible for the overall coordination and administration of
 
 assigning, SPL submissions and maintaining a list of the product codes and packaging
 codes and assigning NDC numbers to Ion manufactured over-the-counter product. The
 
 QA department will maintain a master list of all assigned NDC numbers.
 
 3.2 The Vice President of Regulatory Affairs and Quality Assurance is responsible for
 
 assuring that all provisions of this SOP are adhered to. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 National Drug Code (NDC) Coding C-604 1 Page 2 of 5 
 
 3.3 Research and Development is responsible for submitting Ion Lab over-the counter final
 approved drug formulas and raw material information to QA. 
 
 3.4 The Labeling Department is responsible for submitting Ion Lab manufactured finished
 product over-the-counter final approved labeling information to QA.
 
 4.0 Definitions 
 
 4.1 QA — Quality Assurance 
 
 4.2 NDC — National Drug Code —Drugs are identified and reported using a unique, three —
 
 segment number, called the National Drug Code (NDC), which serves as the FDA’s
 universal product identifier for drugs. 
 
 4.3 cGMP —- current Good Manufacturing Practice 
 
 4.4 DBPR -— State of Florida Department of Business and Professional Regulation -The
 Division of Drugs, Devices and Cosmetics safeguards the health, safety, and welfare of the
 
 citizens of the state of Florida from injury due to the use of adulterated, contaminated,
 misbranded drugs, drug ingredients and cosmetics by administering the provisions of the
 
 Florida Drug and Cosmetic Act (Chapter 499, F.S.). SPL — Structured Product Labeling —
 is a document markup standard approved by Health Level Seven (HL7) and adopted by
 
 FDA as a mechanism for exchanging product and facility information and employs
 Extensible Markup Language (XML) 
 
 4.5 Xforms — Software to create SPL files based on XForms technology 
 
 4.6 OTC — Over-the counter 
 
 4.7 CARES Act —FDA Law created to aid response efforts and ease the economic impact
 of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes
 
 statutory provisions that reform and modernize the way OTC monograph drugs are
 
 regulated in the United States. The CARES Act also provides FDA the authority to
 assess and collect user fees dedicated to OTC monograph drug activities.
 
 

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 Standard Operating Procedure SOP No | Rev 
 National Drug Code (NDC) Coding C-604 1 Page 3 of 5 
 
 5.0 References 
 
 5.1 Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. §360))
 
 D2 The National Drug Code Directory, CDER, US FDA 
 
 5.3 Annex B — The Drug Listing Act of 1972 Information Bullet 
 
 5.4 National Drug Code Directory 
 
 5.5 CDER Direct / Xforms (Electronic registration and listing) 
 
 5.6 Structured Product Labeling Resources 
 
 6.0 Procedure 
 
 6.1 The process of requesting a NDC be assigned to Ion manufactured product may be
 
 initiated by forwarding to QA final approved labeling documents, formulation
 documents, and/or approved product profile documents. 
 
 6.2 The NDC code for Ion manufactured over-the-counter product shall consist of labeler
 
 code, product code and package code. It should not exceed 10 digits. Format of the
 
 NDC number shall be as follows: 
 
 6.2.1 69581-XXX-ZZ, 1.e. Ion Lab’s labeler code, XXX = product code, ZZ =
 
 package code. 
 
 6.3 The first set of numbers in the NDC identifies Ion Lab’s labeler code (manufacturer,
 
 repackager, or distributor). 
 
 6.4 The second set of numbers is the product code, which identifies the specific strength,
 
 dosage form (1.e., capsule, tablet, liquid) and formulation of a drug for a specific
 
 company. 
 
 6.5 The third set of numbers is the package code, which identifies package size and type.
 
 6.6 Ion Labs will submit to the FDA a Labeler Code Request, when necessary.
 
 

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 Standard Operating Procedure SOP No | Rev 
 National Drug Code (NDC) Coding C-604 1 Page 4 of 5 
 
 6.7 The FDA assigns a labeler code to Ion labs. 
 
 6.8 The QA Department will assign the product and package code and shall maintain a
 
 master list of assigned Ion Lab’s NDC numbers in the QA files. Regulatory
 registrations and associated documents will be maintained by QA. 
 
 6.9 Ion Labs will assign a unique NDC number and list all over-the-counter drug products it
 
 produces for commercial distribution. 
 
 6.10 Ion Labs will utilize an outside 3" party registration service to perform NDC number
 
 submissions in Structured Product Label format to the FDA to be filed in the national
 NDC directory, when appropriate. 
 
 6.10.1 Human drugs that are not in final marketed form are not included for view in the
 
 NDC directory, however are listed in the National Unfinished Drugs Database
 File. 
 
 6.11 Once Ion Lab’s assigns an NDC code to one product it may not be later reassigned to a
 
 different product. 
 
 6.12 After the initial product listing, if there is a revision to the labeling, an update to the
 
 SPL will be initiated. The updated submission shall be maintained in the QA files.
 
 6.13 If any changes occur in product characteristics, including a change in dosage form,
 active ingredient(s), strength or concentration, route of administration, or product name,
 
 a new NDC will be assigned to the new product version. 
 
 6.14 Different over-the-counter product formulations or different strengths of the same
 
 formulation will be assigned a different product code. 
 
 6.15 Any over-the counter drug product that shares the same formulation but has different
 product characteristics that clearly distinguish one product version from another will
 
 not share the same product code under the same labeler code and will be assigned
 different codes. 
 
 6.16 If Ion Labs no longer plans to manufacture an NDC listed product, Ion will also submit
 
 an “end of marketing date” submission and the end date will be the date of the last
 batch or lot of the over-the-counter drug manufactured. 
 
 

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 Standard Operating Procedure SOP No Rev 
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 National Drug Code (NDC) Coding 
 
 6.17 OTC drug products also will be registered with the State of Florida (referencing the
 NDC Code). The appropriate information, labeling, and fee will be submitted
 
 appropriately with the DBPR. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/26/19 | New procedure N/A L. Vick 08/05/22 Revise procedure to reference applicable regulation and guidance. CC-22-0337 S. Millar | - | - |