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United States · US · US:55292-201_399a2f13-1fa5-5557-e063-6294a90a48a2

Chemet

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRecordati Rare Diseases, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5529220111
    100 CAPSULE in 1 BOTTLE (55292-201-11)

Annotations

UNII (FDA Substance ID)
DX1U2629QE
SUCCIMER
RxCUI 3446
Orange Book
N019998
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "DX1U2629QE",
    "rxcui": "3446",
    "inchikey": "ACTRVOBWPAIOHC-XIXRPRMCSA-N",
    "display_name": "SUCCIMER",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "62035612-9505-3a3f-1ac8-e2dbd711d24e": {
      "match": "brand_token",
      "title": "CHEMET (SUCCIMER) CAPSULE [RECORDATI RARE DISEASES, INC.]",
      "spl_version": "10",
      "published_date": "2025-07-14"
    }
  },
  "productid": "55292-201_399a2f13-1fa5-5557-e063-6294a90a48a2",
  "productndc": "55292-201",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "019998",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 30, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUCCIMER",
  "proprietary_name": "Chemet",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019998",
  "marketing_category": "NDA",
  "nonproprietary_name": "succimer",
  "start_marketing_date": "20130821",
  "active_numerator_strength": "100"
}

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