🇺🇸
United States · US · US:42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6
Endari
Orange BookUNIISPLATC A16AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEmmaus Medical, Inc.
CountryUS (United States)
ATC codeA16AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11424574206060 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)
Annotations
UNII (FDA Substance ID)
0RH81L854J
GLUTAMINE
RxCUI 4885
Orange Book
N208587
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0RH81L854J",
"rxcui": "4885",
"inchikey": "ZDXPYRJPNDTMRX-VKHMYHEASA-N",
"display_name": "GLUTAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d5a783f4-12ef-4326-8faa-40018e45ba3b": {
"match": "brand_token",
"title": "ENDARI (GLUTAMINE) POWDER, FOR SOLUTION [EMMAUS MEDICAL, INC.]",
"spl_version": "10",
"published_date": "2025-06-27"
}
},
"productid": "42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6",
"productndc": "42457-420",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "208587",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "5GM/PACKET",
"product_no": "001",
"approval_date": "Jul 7, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLUTAMINE",
"proprietary_name": "Endari",
"active_ingred_unit": "g/1",
"application_number": "NDA208587",
"marketing_category": "NDA",
"nonproprietary_name": "Glutamine",
"start_marketing_date": "20170707",
"active_numerator_strength": "5"
}Related drugs
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