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United States · US · US:0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5

Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN05AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0121065402
    60 mL in 1 BOTTLE (0121-0654-02)
  • ndc11
    0121065416
    473 mL in 1 BOTTLE (0121-0654-16)

Annotations

UNII (FDA Substance ID)
ZOU145W1XL
FLUPHENAZINE HYDROCHLORIDE
RxCUI 203207
Orange Book
A040146
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": "ORAL",
  "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": "0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5",
  "productndc": "0121-0654",
  "dosage_form": "ELIXIR",
  "orange_book": {
    "appl_no": "040146",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG/5ML",
        "product_no": "001",
        "approval_date": "Aug 21, 1996"
      }
    ],
    "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": "ANDA040146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20100831",
  "active_numerator_strength": ".5"
}

Related drugs

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