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United States · US · US:0310-6512_7333a7dd-9449-4c61-b36d-c5d8d7cc239b
Byetta
Orange BookUNIISPLATC A10BJ01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA10BJ01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103106512011 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
9P1872D4OL
EXENATIDE
RxCUI 60548
Orange Book
N021773
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9P1872D4OL",
"rxcui": "60548",
"inchikey": null,
"display_name": "EXENATIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"53d03c03-ebf7-418d-88a8-533eabd2ee4f": {
"match": "brand_token",
"title": "BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "26",
"published_date": "2025-09-08"
}
},
"productid": "0310-6512_7333a7dd-9449-4c61-b36d-c5d8d7cc239b",
"productndc": "0310-6512",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "021773",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "300MCG/1.2ML (250MCG/ML)",
"product_no": "001",
"approval_date": "Apr 28, 2005"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "600MCG/2.4ML (250MCG/ML)",
"product_no": "002",
"approval_date": "Apr 28, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EXENATIDE",
"proprietary_name": "Byetta",
"active_ingred_unit": "ug/mL",
"application_number": "NDA021773",
"marketing_category": "NDA",
"nonproprietary_name": "exenatide",
"start_marketing_date": "20141210",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code A10BJ01.
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