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United States · US · US:50090-2126_e39bafb7-205b-4ad7-9391-df7c04a88c12

Metronidazole

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD06BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009021260
    70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0)

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
N020208
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": "VAGINAL",
  "spl_meta": {
    "74cf111a-9b83-4f93-b0e8-bc252d471d43": {
      "match": "brand_token",
      "title": "METRONIDAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED]",
      "spl_version": "11",
      "published_date": "2026-05-20"
    }
  },
  "productid": "50090-2126_e39bafb7-205b-4ad7-9391-df7c04a88c12",
  "productndc": "50090-2126",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "020208",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.75%",
        "product_no": "001",
        "approval_date": "Aug 17, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRONIDAZOLE",
  "shortage_reason": "Metronidazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Metronidazole",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020208",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "metronidazole",
  "start_marketing_date": "20150401",
  "active_numerator_strength": "7.5"
}

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