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United States · US · US:50090-6417_1e4f7dd7-60f2-433d-9971-96b9576a4666

Cefdinir

Orange BookUNIISPLATC J01DD15

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01DD15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009064170
    1 BOTTLE in 1 CARTON (50090-6417-0) / 60 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A065473
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CI0FAO63WC",
    "rxcui": "25037",
    "inchikey": "RTXOFQZKPXMALH-GHXIOONMSA-N",
    "display_name": "CEFDINIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a8029f7c-6353-46db-8c8c-c86a9485a14f": {
      "match": "brand_token",
      "title": "CEFDINIR CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-05-20"
    }
  },
  "productid": "50090-6417_1e4f7dd7-60f2-433d-9971-96b9576a4666",
  "productndc": "50090-6417",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065473",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 14, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "002",
        "approval_date": "Dec 14, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFDINIR",
  "proprietary_name": "Cefdinir",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065473",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefdinir",
  "start_marketing_date": "20071214",
  "active_numerator_strength": "125"
}

Related drugs

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