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United States · US · US:0169-4303_5176eed4-f8f8-4f88-a079-11f16864f40a
RYBELSUS
Orange BookUNIIATC A10BJ06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovo Nordisk Pharmaceutical Industries, LP
CountryUS (United States)
ATC codeA10BJ06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11016943033030 TABLET in 1 BOTTLE, GLASS (0169-4303-30)
- ndc11016943039930 TABLET in 1 BOTTLE, GLASS (0169-4303-99)
Annotations
UNII (FDA Substance ID)
53AXN4NNHX
SEMAGLUTIDE
RxCUI 1991302
Orange Book
N213051
Raw payload (JSON)
{
"unii": {
"unii": "53AXN4NNHX",
"rxcui": "1991302",
"inchikey": null,
"display_name": "SEMAGLUTIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "0169-4303_5176eed4-f8f8-4f88-a079-11f16864f40a",
"productndc": "0169-4303",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213051",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "001",
"approval_date": "Sep 20, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "7MG",
"product_no": "002",
"approval_date": "Sep 20, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "14MG",
"product_no": "003",
"approval_date": "Sep 20, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.5MG",
"product_no": "004",
"approval_date": "Dec 9, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4MG",
"product_no": "005",
"approval_date": "Dec 9, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "006",
"approval_date": "Dec 9, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEMAGLUTIDE",
"proprietary_name": "RYBELSUS",
"active_ingred_unit": "mg/1",
"application_number": "NDA213051",
"marketing_category": "NDA",
"nonproprietary_name": "oral semaglutide",
"start_marketing_date": "20190920",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code A10BJ06.
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