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United States · US · US:21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a

Metronidazole Vaginal Gel, 0.75%

In shortageOrange BookUNIISPLATC D06BX01

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

Identification

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

Packs · 1

  • ndc11
    2192203923
    1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A215610
AB
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": "21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a",
  "productndc": "21922-039",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "215610",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.75%",
        "product_no": "001",
        "approval_date": "Jun 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRONIDAZOLE",
  "shortage_reason": "Metronidazole Injection",
  "shortage_status": "current",
  "proprietary_name": "Metronidazole Vaginal Gel, 0.75%",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA215610",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metronidazole",
  "start_marketing_date": "20230617",
  "active_numerator_strength": "7.5"
}

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