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United States · US · US:0169-4130_852fff2d-704e-4b01-9244-439a28094202
Ozempic
Orange BookUNIISPLATC 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 · 1
- ndc1101694130131 SYRINGE, PLASTIC in 1 CARTON (0169-4130-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4130-01)
Annotations
UNII (FDA Substance ID)
53AXN4NNHX
SEMAGLUTIDE
RxCUI 1991302
Orange Book
N209637
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "53AXN4NNHX",
"rxcui": "1991302",
"inchikey": null,
"display_name": "SEMAGLUTIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"adec4fd2-6858-4c99-91d4-531f5f2a2d79": {
"match": "brand_token",
"title": "OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK PHARMACEUTICAL INDUSTRIES, LP]",
"spl_version": "19",
"published_date": "2026-05-21"
}
},
"productid": "0169-4130_852fff2d-704e-4b01-9244-439a28094202",
"productndc": "0169-4130",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209637",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "2MG/1.5ML (1.34MG/ML)",
"product_no": "001",
"approval_date": "Dec 5, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4MG/3ML (1.34MG/ML)",
"product_no": "002",
"approval_date": "Apr 9, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "8MG/3ML (2.68MG/ML)",
"product_no": "003",
"approval_date": "Mar 28, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG/3ML (0.68MG/ML)",
"product_no": "004",
"approval_date": "Oct 6, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEMAGLUTIDE",
"proprietary_name": "Ozempic",
"active_ingred_unit": "mg/mL",
"application_number": "NDA209637",
"marketing_category": "NDA",
"nonproprietary_name": "semaglutide",
"start_marketing_date": "20200930",
"active_numerator_strength": "1.34"
}Related drugs
Other records sharing ATC code A10BJ06.
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