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United States · US · US:71863-114_ce6d0fd4-bbe0-4a22-bfb5-33326b63a67f
Carglumic Acid
Orange BookUNIISPLATC A16AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEton Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171863114601 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5L0HB4V1EW
CARGLUMIC ACID
RxCUI 401713
Orange Book
A213729
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5L0HB4V1EW",
"rxcui": "401713",
"inchikey": "LCQLHJZYVOQKHU-VKHMYHEASA-N",
"display_name": "CARGLUMIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"591f95ca-3d99-4fb6-a402-e5a383a746d0": {
"match": "brand_token",
"title": "CARGLUMIC ACID TABLET, FOR SUSPENSION [ETON PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2026-03-05"
}
},
"productid": "71863-114_ce6d0fd4-bbe0-4a22-bfb5-33326b63a67f",
"productndc": "71863-114",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "213729",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Oct 13, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARGLUMIC ACID",
"proprietary_name": "Carglumic Acid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213729",
"marketing_category": "ANDA",
"nonproprietary_name": "Carglumic Acid",
"start_marketing_date": "20211220",
"active_numerator_strength": "200"
}Related drugs
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