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
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
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:
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