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United States · US · US:50090-5949_a5c23c93-1c61-4768-b7f2-1e430cd21a8d
Ozempic
Orange BookUNIISPLATC A10BJ06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BJ06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090594901 SYRINGE, PLASTIC in 1 CARTON (50090-5949-0) / 3 mL in 1 SYRINGE, PLASTIC
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": "50090-5949_a5c23c93-1c61-4768-b7f2-1e430cd21a8d",
"productndc": "50090-5949",
"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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