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United States · US · US:65862-752_141b12c3-31de-4ca7-ac89-d864975846ab

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
    6586275250
    50 mL in 1 BOTTLE (65862-752-50)
  • ndc11
    6586275275
    75 mL in 1 BOTTLE (65862-752-75)

Annotations

UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
A204835
ABAB
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": "65862-752_141b12c3-31de-4ca7-ac89-d864975846ab",
  "productndc": "65862-752",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "204835",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 14, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/5ML",
        "product_no": "002",
        "approval_date": "Apr 14, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIXIME",
  "proprietary_name": "Cefixime",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204835",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cefixime",
  "start_marketing_date": "20150414",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J01DD08.

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