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United States · US · US:50268-368_2b4993c9-b528-9f47-e063-6394a90a7a4d

Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeN05AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026836815
    50 BLISTER PACK in 1 BOX (50268-368-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-368-11)

Annotations

UNII (FDA Substance ID)
ZOU145W1XL
FLUPHENAZINE HYDROCHLORIDE
RxCUI 203207
Orange Book
A214534
ABABABAB
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": "50268-368_2b4993c9-b528-9f47-e063-6394a90a7a4d",
  "productndc": "50268-368",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214534",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jan 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jan 7, 2021"
      }
    ],
    "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/1",
  "application_number": "ANDA214534",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20220706",
  "active_numerator_strength": "5"
}

Related drugs

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