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United States · US · US:0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5

Nuvessa

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerExeltis USA, Inc.
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0642746605
    1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR
  • ndc11
    0642746606
    1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
N205223
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Metronidazole Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "140QMO216E",
    "rxcui": "6922",
    "inchikey": "VAOCPAMSLUNLGC-UHFFFAOYSA-N",
    "display_name": "METRONIDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "3b6ff39d-f84b-43b3-9b07-c0521c6d7968": {
      "match": "brand_token",
      "title": "NUVESSA (METRONIDAZOLE) GEL [EXELTIS USA, INC.]",
      "spl_version": "9",
      "published_date": "2023-11-13"
    }
  },
  "productid": "0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5",
  "productndc": "0642-7466",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "205223",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.3%",
        "product_no": "001",
        "approval_date": "Mar 24, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRONIDAZOLE",
  "shortage_reason": "Metronidazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Nuvessa",
  "active_ingred_unit": "mg/5g",
  "application_number": "NDA205223",
  "marketing_category": "NDA",
  "nonproprietary_name": "metronidazole",
  "start_marketing_date": "20180310",
  "active_numerator_strength": "65"
}

Related drugs

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