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United States · US · US:68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40
Carglumic acid
Orange BookUNIISPLATC A16AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNavinta LLC
CountryUS (United States)
ATC codeA16AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168475006015 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)
- ndc11684750060260 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02)
Annotations
UNII (FDA Substance ID)
5L0HB4V1EW
CARGLUMIC ACID
RxCUI 401713
Orange Book
A213395
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": "68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40",
"productndc": "68475-006",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "213395",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jun 22, 2022"
}
],
"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": "ANDA213395",
"marketing_category": "ANDA",
"nonproprietary_name": "Carglumic acid",
"start_marketing_date": "20220801",
"active_numerator_strength": "200"
}Related drugs
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