🇺🇸
United States · US · US:21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c
Metronidazole Vaginal Gel
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
- ndc1121922046411 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A216795
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": "21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c",
"productndc": "21922-046",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "216795",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.3%",
"product_no": "001",
"approval_date": "Mar 18, 2024"
}
],
"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",
"active_ingred_unit": "mg/5g",
"application_number": "ANDA216795",
"marketing_category": "ANDA",
"nonproprietary_name": "Metronidazole vaginal gel, 1.3 %",
"start_marketing_date": "20240319",
"active_numerator_strength": "65"
}Related drugs
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