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United States · US · US:59651-647_9cdb156f-7a99-413e-b49a-ffafaf9e93fe

Cefixime

Orange BookUNIISPLATC J01DD08

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965164710
    1 BLISTER PACK in 1 CARTON (59651-647-10) / 10 CAPSULE in 1 BLISTER PACK
  • ndc11
    5965164750
    50 CAPSULE in 1 BOTTLE (59651-647-50)

Annotations

UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
A217607
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "97I1C92E55",
    "rxcui": "25033",
    "inchikey": "IPYWNMVPZOAFOQ-NABDTECSSA-N",
    "display_name": "CEFIXIME",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b5a3c547-3bc7-4856-af9c-1bead294f5d9": {
      "match": "brand_token",
      "title": "CEFIXIME TABLET [RISING PHARMA HOLDINGS, INC.]",
      "spl_version": "3",
      "published_date": "2026-04-13"
    }
  },
  "productid": "59651-647_9cdb156f-7a99-413e-b49a-ffafaf9e93fe",
  "productndc": "59651-647",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217607",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Mar 23, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIXIME",
  "proprietary_name": "Cefixime",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217607",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefixime",
  "start_marketing_date": "20260323",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01DD08.

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