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United States · US · US:68071-3156_2d53fd8c-5f3f-8b3f-e063-6394a90a3ea0

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
    6807131566
    60 mL in 1 BOTTLE (68071-3156-6)

Annotations

UNII (FDA Substance ID)
6E7SN358SE
CEFDINIR MONOHYDRATE
RxCUI 1306064
Orange Book
A065332
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6E7SN358SE",
    "rxcui": "1306064",
    "inchikey": "QWUVJQSNISEEQI-KYIYMPJCSA-N",
    "display_name": "CEFDINIR MONOHYDRATE",
    "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": "68071-3156_2d53fd8c-5f3f-8b3f-e063-6394a90a3ea0",
  "productndc": "68071-3156",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065332",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "May 4, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "002",
        "approval_date": "May 4, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFDINIR MONOHYDRATE",
  "proprietary_name": "Cefdinir",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065332",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefdinir",
  "start_marketing_date": "20070508",
  "active_numerator_strength": "125"
}

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