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United States · US · US:67877-584_30690cba-b831-45c1-b799-a013d6cfc2db

CEFIXIME

Orange BookUNIISPLATC J01DD08

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeJ01DD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6787758401
    100 CAPSULE in 1 BOTTLE (67877-584-01)
  • ndc11
    6787758405
    500 CAPSULE in 1 BOTTLE (67877-584-05)
  • ndc11
    6787758433
    10 BLISTER PACK in 1 CARTON (67877-584-33) / 10 CAPSULE in 1 BLISTER PACK
  • ndc11
    6787758450
    50 CAPSULE in 1 BOTTLE (67877-584-50)

Annotations

UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
A210574
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": "67877-584_30690cba-b831-45c1-b799-a013d6cfc2db",
  "productndc": "67877-584",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210574",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Oct 9, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIXIME",
  "proprietary_name": "CEFIXIME",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210574",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEFIXIME",
  "start_marketing_date": "20181012",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01DD08.

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