Product Package Structure & Examples
Structure Overview
These structures describe how drug products are packaged and labelled for distribution. Drug products may be packaged on their own, or in combination with other drug products as a kit. The packaging for a product may have multiple levels (i.e. an inner package within an outer package). An example of a simple package containing a single drug product and one level of packaging is shown below:
{
"package_ndc_code": "50580-0111-08",
"description": "240 mL in 1 BOTTLE, PLASTIC",
"amount": "240",
"unit": "mL",
"form": "BOTTLE, PLASTIC",
"for_product": {
"ndc_product_code": "50580-0111",
"name": "Tylenol Extra Strength",
"active_ingredients": [
{
"name": "Acetaminophen",
"unii": "362O9ITL9D",
"strength_number": "500",
"strength_unit": "mg/15mL"
}
],
"inactive_ingredients": [
{
"name": "anhydrous citric acid",
"unii": "XF417D3PSL",
"strength_number": null,
"strength_unit": null
},
{
"name": "D&C Red NO. 33",
"unii": "9DBA0SBB0L",
"strength_number": null,
"strength_unit": null
},
{
"name": "FD&C Red NO. 40",
"unii": "WZB9127XOA",
"strength_number": null,
"strength_unit": null
},
{
"name": "high fructose corn syrup",
"unii": "XY6UN3QB6S",
"strength_number": null,
"strength_unit": null
},
{
"name": "polyethylene glycols",
"unii": "3WJQ0SDW1A",
"strength_number": null,
"strength_unit": null
},
{
"name": "propylene glycol",
"unii": "6DC9Q167V3",
"strength_number": null,
"strength_unit": null
},
{
"name": "water",
"unii": "059QF0KO0R",
"strength_number": null,
"strength_unit": null
},
{
"name": "saccharin sodium",
"unii": "SB8ZUX40TY",
"strength_number": null,
"strength_unit": null
},
{
"name": "sodium benzoate",
"unii": "OJ245FE5EU",
"strength_number": null,
"strength_unit": null
},
{
"name": "sorbitol",
"unii": "506T60A25R",
"strength_number": null,
"strength_unit": null
}
]
},
"packaging_tree": [
{
"package_ndc_code": "50580-0111-08",
"description": "240 mL in 1 BOTTLE, PLASTIC",
"amount": "240",
"unit": "mL",
"form": "BOTTLE, PLASTIC"
}
]
}Multi-level Packaging
A single drug product can have any number of levels of packaging. It can also have multiple package combinations. Below is an example of a package that can have three different types of outer packaging:
{
"package_ndc_code": "00002-1445-01",
"description": "1 mL in 1 SYRINGE",
"amount": "1",
"unit": "mL",
"form": "SYRINGE",
"for_product": {
"ndc_product_code": "00002-1445",
"name": "Taltz",
"active_ingredients": [
{
"name": "ixekizumab",
"unii": "BTY153760O",
"strength_number": "80",
"strength_unit": "mg/1mL"
}
],
"inactive_ingredients": [
{
"name": "Anhydrous Citric Acid",
"unii": "XF417D3PSL",
"strength_number": "0.51",
"strength_unit": "mg/1mL"
},
{
"name": "Polysorbate 80",
"unii": "6OZP39ZG8H",
"strength_number": "0.30",
"strength_unit": "mg/1mL"
},
{
"name": "Sodium Chloride",
"unii": "451W47IQ8X",
"strength_number": "11.69",
"strength_unit": "mg/1mL"
},
{
"name": "Trisodium Citrate Dihydrate",
"unii": "B22547B95K",
"strength_number": "5.11",
"strength_unit": "mg/1mL"
},
{
"name": "Water",
"unii": "059QF0KO0R",
"strength_number": null,
"strength_unit": null
}
]
},
"packaging_tree": [
{
"package_ndc_code": "00002-1445-11",
"description": "1 in 1 CARTON",
"amount": "1",
"unit": "1",
"form": "CARTON",
"content": {
"package_ndc_code": "00002-1445-01",
"description": "1 mL in 1 SYRINGE",
"amount": "1",
"unit": "mL",
"form": "SYRINGE"
}
},
{
"package_ndc_code": "00002-1445-27",
"description": "2 in 1 CARTON",
"amount": "2",
"unit": "1",
"form": "CARTON",
"content": {
"package_ndc_code": "00002-1445-01",
"description": "1 mL in 1 SYRINGE",
"amount": "1",
"unit": "mL",
"form": "SYRINGE"
}
},
{
"package_ndc_code": "00002-1445-09",
"description": "3 in 1 CARTON",
"amount": "3",
"unit": "1",
"form": "CARTON",
"content": {
"package_ndc_code": "00002-1445-01",
"description": "1 mL in 1 SYRINGE",
"amount": "1",
"unit": "mL",
"form": "SYRINGE"
}
}
]
}This package is a 1 mL in 1 SYRINGE that can be found in a 3 in 1 CARTON, 2 in 1 CARTON and 1 in 1 CARTON.
Kits
A package that contains multiple products is a kit. Each of these products is represented as a part that has its own product and packaging. The packaged parts are assumed to be contained within the kit packaging. An example of a kit with parts is shown below:
{
"package_ndc_code": "68405-0018-06",
"description": "1 in 1 KIT",
"amount": "1",
"unit": "1",
"form": "KIT",
"for_product": {
"ndc_product_code": "68405-0018",
"name": "Theraproxen-90",
"active_ingredients": [
{
"name": "NAPROXEN",
"unii": "57Y76R9ATQ",
"strength_number": "250",
"strength_unit": "mg/1"
},
{
"name": ".GAMMA.-AMINOBUTYRIC ACID",
"unii": "2ACZ6IPC6I",
"strength_number": "100",
"strength_unit": "mg/1"
}
],
"inactive_ingredients": [
{
"name": "CROSCARMELLOSE SODIUM",
"unii": "M28OL1HH48",
"strength_number": null,
"strength_unit": null
},
{
"name": "POVIDONE",
"unii": "FZ989GH94E",
"strength_number": null,
"strength_unit": null
},
{
"name": "MAGNESIUM STEARATE",
"unii": "70097M6I30",
"strength_number": null,
"strength_unit": null
},
{
"name": "MAGNESIUM STEARATE",
"unii": "70097M6I30",
"strength_number": null,
"strength_unit": null
},
{
"name": "CELLULOSE, MICROCRYSTALLINE",
"unii": "OP1R32D61U",
"strength_number": null,
"strength_unit": null
},
{
"name": "MALTODEXTRIN",
"unii": "7CVR7L4A2D",
"strength_number": null,
"strength_unit": null
},
{
"name": "GELATIN",
"unii": "2G86QN327L",
"strength_number": null,
"strength_unit": null
}
]
},
"parts": [
{
"number": 1,
"ndc_product_code": "52959-0190",
"name": "NAPROXEN",
"route": "ORAL",
"amount": "60",
"unit": "1",
"dosage_form": "TABLET",
"marketing_category": "ANDA",
"application_number": "ANDA075927",
"packaging_tree": [
{
"package_ndc_code": "52959-0190-30",
"description": "60 in 1 BOTTLE",
"amount": "60",
"unit": "1",
"form": "BOTTLE"
}
],
"active_ingredients": [
{
"name": "NAPROXEN",
"unii": "57Y76R9ATQ",
"strength_number": "250",
"strength_unit": "mg/1"
}
],
"inactive_ingredients": [
{
"name": "CROSCARMELLOSE SODIUM",
"unii": "M28OL1HH48",
"strength_number": null,
"strength_unit": null
},
{
"name": "POVIDONE",
"unii": "FZ989GH94E",
"strength_number": null,
"strength_unit": null
},
{
"name": "MAGNESIUM STEARATE",
"unii": "70097M6I30",
"strength_number": null,
"strength_unit": null
}
]
},
{
"number": 2,
"ndc_product_code": null,
"name": "Theramine",
"route": "ORAL",
"amount": "90",
"unit": "1",
"dosage_form": "CAPSULE",
"marketing_category": "MEDICAL FOOD",
"application_number": null,
"packaging_tree": [
{
"package_ndc_code": null,
"description": "90 in 1 BOTTLE",
"amount": "90",
"unit": "1",
"form": "BOTTLE"
}
],
"active_ingredients": [
{
"name": ".GAMMA.-AMINOBUTYRIC ACID",
"unii": "2ACZ6IPC6I",
"strength_number": "100",
"strength_unit": "mg/1"
}
],
"inactive_ingredients": [
{
"name": "MAGNESIUM STEARATE",
"unii": "70097M6I30",
"strength_number": null,
"strength_unit": null
},
{
"name": "CELLULOSE, MICROCRYSTALLINE",
"unii": "OP1R32D61U",
"strength_number": null,
"strength_unit": null
},
{
"name": "MALTODEXTRIN",
"unii": "7CVR7L4A2D",
"strength_number": null,
"strength_unit": null
},
{
"name": "GELATIN",
"unii": "2G86QN327L",
"strength_number": null,
"strength_unit": null
}
]
}
],
"packaging_tree": [
{
"package_ndc_code": "68405-0018-06",
"description": "1 in 1 KIT",
"amount": "1",
"unit": "1",
"form": "KIT"
}
]
}This package is a kit containing two parts, NAPROXEN and Theramine.
Note that a kit and its parts can still have multiple levels and combinations of packaging.
If a package is part of a kit, it will be represented like the example below:
{
"package_ndc_code": "52959-0190-30",
"description": "60 in 1 BOTTLE",
"amount": "60",
"unit": "1",
"form": "BOTTLE",
"for_part": {
"ndc_product_code": "52959-0190",
"name": "NAPROXEN",
"active_ingredients": [
{
"name": "NAPROXEN",
"unii": "57Y76R9ATQ",
"strength_number": "250",
"strength_unit": "mg/1"
}
],
"inactive_ingredients": [
{
"name": "CROSCARMELLOSE SODIUM",
"unii": "M28OL1HH48",
"strength_number": null,
"strength_unit": null
},
{
"name": "POVIDONE",
"unii": "FZ989GH94E",
"strength_number": null,
"strength_unit": null
},
{
"name": "MAGNESIUM STEARATE",
"unii": "70097M6I30",
"strength_number": null,
"strength_unit": null
}
]
},
"packaging_tree": [
{
"package_ndc_code": "52959-0190-30",
"description": "60 in 1 BOTTLE",
"amount": "60",
"unit": "1",
"form": "BOTTLE"
}
],
"part_of": [
{
"package_ndc_code": "68405-0018-06",
"description": "1 in 1 KIT",
"product": {
"ndc_product_code": "68405-0018",
"name": "Theraproxen-90"
}
},
{
"package_ndc_code": "68405-0016-36",
"description": "1 in 1 KIT",
"product": {
"ndc_product_code": "68405-0016",
"name": "Trepoxen-250"
}
},
{
"package_ndc_code": "68405-0180-06",
"description": "1 in 1 KIT",
"product": {
"ndc_product_code": "68405-0180",
"name": "Theraproxen"
}
}
]
}This package is a found in Theraproxen-90, Theraproxen-250, and Theraproxen kits.
For full details on package attributes, see the Data Details page.