Back to search
🇺🇸

United States · US · US:68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4

CEFIXIME

Orange BookUNIISPLATC J01DD08

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

Identification

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

Packs · 2

  • ndc11
    6818042308
    50 CAPSULE in 1 BOTTLE (68180-423-08)
  • ndc11
    6818042311
    1 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
97I1C92E55
CEFIXIME
RxCUI 25033
Orange Book
N203195
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": "68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4",
  "productndc": "68180-423",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203195",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 1, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIXIME",
  "proprietary_name": "CEFIXIME",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203195",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "CEFIXIME",
  "start_marketing_date": "20201014",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01DD08.

Access this data programmatically

Query CEFIXIME and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.