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United States · US · US:81565-205_09e32400-24f3-4cab-9563-30e9f92dc17d
Fentanyl Citrate
In shortageOrange BookUNIISPLATC N02AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPhlow Corp.
CountryUS (United States)
ATC codeN02AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11815652050225 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01)
Annotations
UNII (FDA Substance ID)
MUN5LYG46H
FENTANYL CITRATE
RxCUI 142436
Orange Book
N019101
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fentanyl Citrate Injection
Raw payload (JSON)
{
"unii": {
"unii": "MUN5LYG46H",
"rxcui": "142436",
"inchikey": "IVLVTNPOHDFFCJ-UHFFFAOYSA-N",
"display_name": "FENTANYL CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"e15a7e9b-8025-49dd-9a6d-bafcccf1959f": {
"match": "brand_token",
"title": "FENTANYL TRANSDERMAL PATCH, EXTENDED RELEASE [SPECGX LLC]",
"spl_version": "58",
"published_date": "2026-05-06"
}
},
"productid": "81565-205_09e32400-24f3-4cab-9563-30e9f92dc17d",
"productndc": "81565-205",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "019101",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 0.05MG BASE/ML",
"product_no": "001",
"approval_date": "Jul 11, 1984"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.025MG BASE/0.5ML",
"product_no": "002",
"approval_date": "Jan 20, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENTANYL CITRATE",
"shortage_reason": "Fentanyl Citrate Injection",
"shortage_status": "current",
"proprietary_name": "Fentanyl Citrate",
"active_ingred_unit": "ug/mL",
"application_number": "NDA019101",
"marketing_category": "NDA",
"nonproprietary_name": "Fentanyl Citrate",
"start_marketing_date": "20230111",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N02AB03.
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