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United States · US · US:68071-3998_5128bf5c-27c8-8a0a-e063-6394a90a8ffa

Cefdinir

Orange BookUNIISPLATC J01DD15

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01DD15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807139982
    2 CAPSULE in 1 BOTTLE (68071-3998-2)

Annotations

UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A065434
AB
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": "68071-3998_5128bf5c-27c8-8a0a-e063-6394a90a8ffa",
  "productndc": "68071-3998",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065434",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFDINIR",
  "proprietary_name": "Cefdinir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065434",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefdinir",
  "start_marketing_date": "20080107",
  "active_numerator_strength": "300"
}

Related drugs

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