National Drug Code (NDC)

1. National Drug Code (NDC)

2. Drug Listing Requirements • Section 510 of the Federal Food, Drug, and Cosmetic Act requires drug firms to list with FDA drug products manufactured, prepared, propagated, compounded, or processed by them for commercial distribution • Drug products are uniquely identified and reported using a 3 segment number, called the National Drug Code (NDC) consisting of the labeler code, the product code and the package code.

3. What is the NDC? • Currently described in the regulations as a unique three segment 10-character code used to identify and report drug products (21 CFR 207.35). • The three segment number consists of the following elements: • Labeler Code • Product Code • Package Code

4. The NDC • Current elements of the three segment NDC: • Labeler Code - assigned by the FDA; labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug • Product Code – assigned by the firm; identifies a specific strength, dosage form, and formulation for a particular firm • Package Code – assigned by the firm; identifies package sizes and types

5. Registration and Listing under FDAAA (Section 224) • FDAAA mandates electronic registration and listing. • FDA intends to only accept electronic drug establishment registration and drug listing information beginning June 1, 2009 • FDA has adopted use of extensible markup language (XML) files in a standard Structured Product Labeling (SPL) format as the standard format for the exchange of drug establishment and listing information

6. Registration and Listing under FDAAA (Section 224) • Electronic drug listing will require codes for drug listing data elements (DLDE). • NDC is a required Drug Listing Data Element in the SPL File

7. Drug Listing Data Elements • Examples of DLDE for verification in a firm’s SPL file • Substance name, UNII (SRS) • Strength • Route of Administration • Dosage Form • Appearance • Package Size and Type • DEA Schedule • NDC number

8. The NDC - Current Status for Allergenics • Currently, NDC assignments for allergenic extracts differ by firm. Examples of differences can be seen on NDC website: http://www.fda.gov/cder/ndc/database/default.htm • Some firms have multiple NDCs for individual extracts • Some firms have NDCs for grouped extracts • Some firms have NDCs for combination extracts • Some firms appear to have a mix of individual, grouped or combination extract NDCs • Some firms appear to have no NDCs or very few NDCs for their extracts

9. The NDC- Current Status for Allergenics • Currently, some firms have some unique NDCs for individual (single antigen) products. The NDCs are not always specific to vial size or strength. Examples from NDC website: • Firm A, NDC 36987 (0387), “Canary Grass” • Firm B, NDC 00268 (0283), “Standardized June Grass Pollen Injection, 100,000 BAU/mL” • Firm C, NDC 22840 (0051), “Allergenic Extract Parakeet Feathers Injection, 5%”

10. The NDC - Current Status for Allergenics • Currently, some firms use NDCs to cover groups of products. • Grouping = covering multiple extracts of a similar type with one NDC number. In these cases, the NDC number does not refer to a specific single antigen species or combination extract, it refers only to the general category of extract. Examples from NDC website: • Firm D, NDC 65044 (9965), “Mold extracts glycerinated, 1 UNT” • Firm E, NDC 49288 (9908),“Allergenic extract, food injection, 10%”

11. The NDC- Current Status for Allergenics • Currently, some firms have NDCs for mixes or combinations. Examples from NDC website: • Firm B, NDC 00268 (0409), “Allergenic extract mix, inhalant insect injection, combo” • Firm A, NDC 36987 (0457), “Allergenic Extract Mixed Epidermis 9, combo”

12. Allergenics Industry Comments on the NDC • Electronic registration and listing proposed rule [71 FR 51276, August 29, 2006] proposed individual NDC numbers for single products, mixtures, different formulations and strengths. • Note that FDA is still considering comments submitted on this proposed rule.

13. Allergenics Industry Comments on the NDC • Firms’ comments generally stated that if individual NDCs are required for every individual allergen extract and stock mixture in every strength and every formulation, the numbers would quickly get unworkable and expensive. • For example, one firm’s comments stated that its BLA contains 650 unique allergens and an additional number of stock mixtures. If only single antigen and stock mixtures are considered, the firm stated that the proposed NDC requirement would result in the necessity to create more than 3500 NDCs to cover its product line.

14. Allergenics Industry Comments on the NDC • Allergenics industry stated that FDA should consider NDC grouping as an alternative. Examples of grouping proposals in comments: • Group products under one NDC by general allergen category – pollens, molds, epidermals, foods, miscellaneous inhalants, etc. • Group products under one NDC by product code and concentration (i.e. one product code used for all non-standardized pollen at 1:20 w/v) • Group by product without differentiating package sizes

15. Issues for Clarification FDA seeks clarification on: • What methodology and rationale do firms currently use to group products under one NDC? • Comments from the allergenics industry stated that the industry would face undue burden in assigning NDCs per individual allergenic products. Please provide information on the exact burdens firms would face in following the individual NDC per product approach.