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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

  • ndc11
    6847500601
    5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)
  • ndc11
    6847500602
    60 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

Other records sharing ATC code A16AA05.

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