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United States · US · US:71288-035_ab03fd88-8988-4165-ab2a-48a5da12c7ba

Contepo

Orange BookUNIISPLATC S02AA17

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS02AA17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128803552
    12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51)

Annotations

UNII (FDA Substance ID)
97MMO19FNO
FOSFOMYCIN SODIUM
Orange Book
N212271
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "97MMO19FNO",
    "rxcui": null,
    "inchikey": "QZIQJIKUVJMTDG-JSTPYPERSA-L",
    "display_name": "FOSFOMYCIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "855574f2-39f8-43bc-a3d2-79dbb578cb94": {
      "match": "brand_token",
      "title": "CONTEPO (FOSFOMYCIN DISODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]",
      "spl_version": "10",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71288-035_ab03fd88-8988-4165-ab2a-48a5da12c7ba",
  "productndc": "71288-035",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "212271",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 6GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 22, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSFOMYCIN SODIUM",
  "proprietary_name": "Contepo",
  "active_ingred_unit": "g/1",
  "application_number": "NDA212271",
  "marketing_category": "NDA",
  "nonproprietary_name": "fosfomycin disodium",
  "start_marketing_date": "20251022",
  "active_numerator_strength": "6"
}

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