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United States · US · US:64980-430_245dc39b-0d41-410f-bbb9-fe1d24eeb8b2

Cefixime

Orange BookUNIISPLATC J01DD08

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeJ01DD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6498043001
    10 TABLET in 1 BOTTLE, PLASTIC (64980-430-01)

Annotations

UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
A206358
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": "64980-430_245dc39b-0d41-410f-bbb9-fe1d24eeb8b2",
  "productndc": "64980-430",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206358",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIXIME",
  "proprietary_name": "Cefixime",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206358",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefixime",
  "start_marketing_date": "20251212",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01DD08.

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