DailyMed

Short Description

FDA structured product label (SPL) information archived in XML format by NLM.

Status

Done

Data Source

NLM

Update Frequency

Data marts

NDCs to label images

DailyMed

Description

FDA structured product label (SPL) information archived in XML format by NLM.

SPL resources

Structured Product Labeling Resources

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

www.fda.gov

SPL implementation guide with validation procedures

www.fda.gov

SPL Schema and Stylesheet

FDA SPL Schema for Implementation(zip file last updated April 25, 2016)
FDA SPL stylesheet (zip file last updated October 24, 2016) - send comments to spl@fda.hhs.gov

Source links

Download

API

Joey LeGrand2 years ago

aww snap Kent Bridgeman DailyMed offers an API for package description in JSON example in commentshdefault

#proj-sagerx

Here's a more complex "KIT / CARTON" examplenote that it has "Part 1 / Part 2" info in great detail - including inner NDCs.

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5bf7a31-7e17-4a94-805c-d231ea458fb0

https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f5bf7a31-7e17-4a94-805c-d231ea458fb0/packaging.json?pagesize=10

(equivalent in FDA NDC Directory packagedescription):

Simple example: 1 VIAL, GLASS in 1 CARTON (61755-026-01) / 2.5 mL in 1 VIAL, GLASS (61755-026-00)
Complex example: 1 KIT in 1 CARTON (61755-042-02) * 1 VIAL, GLASS in 1 CARTON (61755-024-01) / 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) / 11.1 mL in 1 VIAL, GLASS (61755-025-00)

            {
                "packaging": [
                    {
                        "ndc": "61755-042-02",
                        "package_descriptions": [
                            "1  in 1 CARTON"
                        ]
                    }
                ],
                "active_ingredients": [
                    {
                        "strength": "1332 mg in 11.1 mL",
                        "name": "Casirivimab"
                    },
                    {
                        "strength": "300 mg in 2.5 mL",
                        "name": "Casirivimab"
                    },
                    {
                        "strength": "600 mg in 10 mL",
                        "name": "Casirivimab"
                    },
                    {
                        "strength": "1332 mg in 11.1 mL",
                        "name": "Imdevimab"
                    },
                    {
                        "strength": "300 mg in 2.5 mL",
                        "name": "Imdevimab"
                    },
                    {
                        "strength": "600 mg in 10 mL",
                        "name": "Imdevimab"
                    }
                ],
                "parts": {
                    "1": {
                        "part_number": 1,
                        "active_ingredients": [
                            {
                                "strength": "1332 mg in 11.1mL",
                                "name": "Casirivimab"
                            }
                        ],
                        "packaging": [
                            {
                                "ndc": "61755-024-00",
                                "package_descriptions": [
                                    "11.1 mL in 1 VIAL, GLASS"
                                ]
                            },
                            {
                                "ndc": "61755-024-01",
                                "package_descriptions": [
                                    "1  in 1 CARTON"
                                ]
                            }
                        ],
                        "part_name": "Casirivimab",
                        "part_name_generic": "Casirivimab",
                        "package_quantity": "1 VIAL, GLASS",
                        "part_code": "61755-024",
                        "total_product_quantity": "11.1 mL"
                    },
                    "2": {
                        "part_number": 2,
                        "active_ingredients": [
                            {
                                "strength": "1332 mg in 11.1mL",
                                "name": "Imdevimab"
                            }
                        ],
                        "packaging": [
                            {
                                "ndc": "61755-025-00",
                                "package_descriptions": [
                                    "11.1 mL in 1 VIAL, GLASS"
                                ]
                            },
                            {
                                "ndc": "61755-025-01",
                                "package_descriptions": [
                                    "1  in 1 CARTON"
                                ]
                            }
                        ],
                        "part_name": "Imdevimab",
                        "part_name_generic": "Imdevimab",
                        "package_quantity": "1 VIAL, GLASS",
                        "part_code": "61755-025",
                        "total_product_quantity": "11.1 mL"
                    }
                },
                "product_name_generic": "casirivimab and imdevimab",
                "product_name": "casirivimab with imdevimab",
                "product_code": "61755-042"
            },

Analysis

5000 example rows:

data-1714431018751.csv473.5KB

‣

there are 381718 NDCs in FDA database that have a packagedescription

‣

max length of asterisk-containing description is 2430 characters

‣

min length of asterisk-containing description is 48 characters

‣

descriptions that have asterisks (parts) ALWAYS have a KIT component

‣

descriptions that have a KIT component don’t always have asterisks (parts)

Look into this next

NDC = 00025033302

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f

2 KIT in 1 CARTON (0025-0333-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (0025-0329-01) * 1 mL in 1 PACKET (0069-1111-01)

Licensing

Update frequency

Table info

On this page

DailyMed
Description
SPL resources
SPL Schema and Stylesheet
Source links
Download
API
Licensing
Update frequency
Table info