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United States · US · US:63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70
Fluphenazine Hydrochloride
In shortageOrange BookUNIISPLATC N05AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN05AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323281101 VIAL in 1 BOX (63323-281-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
ZOU145W1XL
FLUPHENAZINE HYDROCHLORIDE
RxCUI 203207
Orange Book
A089556
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluphenazine Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "ZOU145W1XL",
"rxcui": "203207",
"inchikey": "MBHNWCYEGXQEIT-UHFFFAOYSA-N",
"display_name": "FLUPHENAZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"044f49f3-f980-4ef8-8beb-78412702cd9d": {
"match": "brand_token",
"title": "FLUPHENAZINE DECANOATE INJECTION, SOLUTION [BRYANT RANCH PREPACK]",
"spl_version": "100",
"published_date": "2026-05-11"
}
},
"productid": "63323-281_cefdb059-d32b-44f2-8dd6-fd2a29b3ba70",
"productndc": "63323-281",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "089556",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "2.5MG/ML",
"product_no": "001",
"approval_date": "Apr 16, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUPHENAZINE HYDROCHLORIDE",
"shortage_reason": "Fluphenazine Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Fluphenazine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA089556",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUPHENAZINE HYDROCHLORIDE",
"start_marketing_date": "20101228",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code N05AB02.
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