🇺🇸
United States · US · US:62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585
BYNFEZIA Pen
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1162756452361 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE
- ndc1162756452372 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
75R0U2568I
OCTREOTIDE ACETATE
RxCUI 221130
Orange Book
N213224
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "75R0U2568I",
"rxcui": "221130",
"inchikey": "QWFYIFWTVZFPRY-LODIGNQBSA-N",
"display_name": "OCTREOTIDE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"20ed4e79-ad4c-426f-859d-83790c00439b": {
"match": "brand_token",
"title": "BYNFEZIA PEN (OCTREOTIDE ACETATE) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "5",
"published_date": "2025-02-25"
}
},
"productid": "62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585",
"productndc": "62756-452",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "213224",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)",
"product_no": "001",
"approval_date": "Sep 27, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OCTREOTIDE ACETATE",
"proprietary_name": "BYNFEZIA Pen",
"active_ingred_unit": "mg/mL",
"application_number": "NDA213224",
"marketing_category": "NDA",
"nonproprietary_name": "octreotide acetate",
"start_marketing_date": "20250224",
"active_numerator_strength": "2.5"
}Related drugs
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