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United States · US · US:63323-596_eb37fc8a-a264-4ce9-a130-466e9b5f3a38
Glucagon
Orange BookUNIISPLATC H04AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeH04AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633235961310 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11)
Annotations
UNII (FDA Substance ID)
1H87NVF4DB
GLUCAGON HYDROCHLORIDE
RxCUI 253170
Orange Book
N201849
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1H87NVF4DB",
"rxcui": "253170",
"inchikey": null,
"display_name": "GLUCAGON HYDROCHLORIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"9d0fbe4e-6120-4f69-b06d-c939eaeb7708": {
"match": "brand_token",
"title": "GLUCAGON KIT [SPORTPHARM LLC]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "63323-596_eb37fc8a-a264-4ce9-a130-466e9b5f3a38",
"productndc": "63323-596",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "201849",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE/VIAL",
"product_no": "001",
"approval_date": "May 8, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE/VIAL",
"product_no": "002",
"approval_date": "Sep 19, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLUCAGON HYDROCHLORIDE",
"proprietary_name": "Glucagon",
"active_ingred_unit": "mg/mL",
"application_number": "NDA201849",
"marketing_category": "NDA",
"nonproprietary_name": "Glucagon",
"start_marketing_date": "20150508",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code H04AA01.
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