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United States · US · US:71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a

Cefdinir

Orange BookUNIISPLATC J01DD15

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01DD15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120522414
    14 CAPSULE in 1 BOTTLE (71205-224-14)
  • ndc11
    7120522420
    20 CAPSULE in 1 BOTTLE (71205-224-20)
  • ndc11
    7120522430
    30 CAPSULE in 1 BOTTLE (71205-224-30)
  • ndc11
    7120522460
    60 CAPSULE in 1 BOTTLE (71205-224-60)
  • ndc11
    7120522490
    90 CAPSULE in 1 BOTTLE (71205-224-90)

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": "71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a",
  "productndc": "71205-224",
  "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

Other records sharing ATC code J01DD15.

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