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United States · US · US:83257-011_3b749417-8933-850b-1373-990e7ee8a312
SEMGLEE
In shortageUNIISPLATC A10AE04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiocon Biologics Inc.
CountryUS (United States)
ATC codeA10AE04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183257011111 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
2ZM8CX04RZ
INSULIN GLARGINE
RxCUI 274783
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Insulin Lispro Injection
Raw payload (JSON)
{
"unii": {
"unii": "2ZM8CX04RZ",
"rxcui": "274783",
"inchikey": null,
"display_name": "INSULIN GLARGINE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"8cf5544f-87d6-468b-f6ae-898b1fdb5d80": {
"match": "brand_token",
"title": "SEMGLEE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.]",
"spl_version": "14",
"published_date": "2026-04-17"
}
},
"productid": "83257-011_3b749417-8933-850b-1373-990e7ee8a312",
"productndc": "83257-011",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INSULIN GLARGINE",
"shortage_reason": "Insulin Lispro Injection",
"shortage_status": "current",
"proprietary_name": "SEMGLEE",
"active_ingred_unit": "[iU]/mL",
"application_number": "BLA761201",
"marketing_category": "BLA",
"nonproprietary_name": "insulin glargine-yfgn",
"start_marketing_date": "20230728",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A10AE04.
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