OpenFDA Human NDC Directory

Short Description

Status

To Do

Data Source

FDA

Update Frequency

Staging Data

Source Data

Description

This may be the most reliable place to find NDC -> set_id. FDA NDC Directory doesn't have this info - it uses the document_id which changes between releases. Set ID is important to link to DailyMed and to automatically link to a label for an NDC, which could be beneficial for many applications. There's also likely tons of other useful info here that we could mine.

Somewhat recently, OpenFDA made these JSON files downloadable to prevent needing to hit the API a billion times.

https://open.fda.gov/data/downloads/

Go to the Human NDC Directory section.

For this first pass, just a DAG to download and unzip this JSON and load it into a datasource table raw I guess. Probably just one row? Not sure if that would work due to database limitations. Possibly better to maybe make a row per NDC with all the JSON for that NDC.

The first staging table would be either product NDC or package NDC -> DailyMed set_id.

✋ Request this data source

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I can't remember if NDC -> set_id is available elsewhere which would reduce the need for this.

There is a user request for this data to be able to automatically pull up a label. See example below.

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c40b15ec-6083-4778-bca8-3e895e5694e1&type=display

Note how the setid is in there and could be programmatically replaced using this data source.

Example below.

In this JSON, we would want:

product_ndc
possibly like a "ndc9" version of the product_ndc without the hyphen and padded to 9 digits
possibly package_ndc, but I don't think it's super necessary to go to this granularity
spl_set_id

    {
      "product_ndc": "0574-2430",
      "generic_name": "methylphenidate",
      "labeler_name": "PADAGIS US LLC",
      "dea_schedule": "CII",
      "brand_name": "Methylphenidate Transdermal System",
      "active_ingredients": [
        {
          "name": "METHYLPHENIDATE",
          "strength": "82.5 mg/mg"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0574-2430-65",
          "description": "1 TRAY in 1 CARTON (0574-2430-65)  / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 82.5 mg in 1 PATCH",
          "marketing_start_date": "20230605",
          "sample": false
        }
      ],
      "listing_expiration_date": "20241231",
      "openfda": {
        "manufacturer_name": [
          "PADAGIS US LLC"
        ],
        "rxcui": [
          "753436",
          "753438",
          "753440",
          "753441"
        ],
        "spl_set_id": [
          "7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175739",
          "N0000175729"
        ],
        "pharm_class_epc": [
          "Central Nervous System Stimulant [EPC]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "unii": [
          "207ZZ9QZ49"
        ]
      },
      "marketing_category": "NDA AUTHORIZED GENERIC",
      "dosage_form": "PATCH",
      "spl_id": "134a3034-e670-488c-99d1-a482109b0a2d",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "TRANSDERMAL"
      ],
      "marketing_start_date": "20230605",
      "product_id": "0574-2430_134a3034-e670-488c-99d1-a482109b0a2d",
      "application_number": "NDA021514",
      "brand_name_base": "Methylphenidate Transdermal System",
      "pharm_class": [
        "Central Nervous System Stimulant [EPC]",
        "Central Nervous System Stimulation [PE]"
      ]
    },

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