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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

  • ndc11
    4245742060
    60 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"
}

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