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United States · US · US:63187-989_a1a1f2d7-b989-41f7-a770-ae1b4b6231ce

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 · 2

  • ndc11
    6318798914
    14 CAPSULE in 1 BOTTLE (63187-989-14)
  • ndc11
    6318798920
    20 CAPSULE in 1 BOTTLE (63187-989-20)

Annotations

UNII (FDA Substance ID)
CI0FAO63WC
CEFDINIR
RxCUI 25037
Orange Book
A065330
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": "63187-989_a1a1f2d7-b989-41f7-a770-ae1b4b6231ce",
  "productndc": "63187-989",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065330",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFDINIR",
  "proprietary_name": "Cefdinir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065330",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefdinir",
  "start_marketing_date": "20070406",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J01DD15.

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