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United States · US · US:0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688
Metronidazole
In shortageOrange BookUNIISPLATC D06BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeD06BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11016803836059 mL in 1 BOTTLE, PLASTIC (0168-0383-60)
Annotations
UNII (FDA Substance ID)
140QMO216E
METRONIDAZOLE
RxCUI 6922
Orange Book
A077197
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": "TOPICAL",
"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": "0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688",
"productndc": "0168-0383",
"dosage_form": "LOTION",
"orange_book": {
"appl_no": "077197",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.75%",
"product_no": "001",
"approval_date": "May 24, 2006"
}
],
"appl_type": "A"
},
"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/mL",
"application_number": "ANDA077197",
"marketing_category": "ANDA",
"nonproprietary_name": "Metronidazole",
"start_marketing_date": "20060524",
"active_numerator_strength": "7.5"
}Related drugs
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