XACIATO

In shortageOrange BookUNIISPLATC G01AA10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7820618901
1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

EH6D7113I8

CLINDAMYCIN PHOSPHATE

RxCUI 797272

Orange Book

N215650

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Clindamycin Phosphate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "EH6D7113I8",
    "rxcui": "797272",
    "inchikey": "UFUVLHLTWXBHGZ-MGZQPHGTSA-N",
    "display_name": "CLINDAMYCIN PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "0423007f-28fa-4159-bf58-9174626d2347": {
      "match": "brand_token",
      "title": "XACIATO (CLINDAMYCIN PHOSPHATE) GEL [ORGANON LLC]",
      "spl_version": "13",
      "published_date": "2026-02-23"
    }
  },
  "productid": "78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91",
  "productndc": "78206-189",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "215650",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Dec 7, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Phosphate Injection",
  "shortage_status": "current",
  "proprietary_name": "XACIATO",
  "active_ingred_unit": "mg/5g",
  "application_number": "NDA215650",
  "marketing_category": "NDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20231013",
  "active_numerator_strength": "100"
}

Related drugs

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