Fluphenazine Hydrochoride

In shortageOrange BookUNIISPLATC N05AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeN05AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1657189209
90 TABLET, FILM COATED in 1 CONTAINER (16571-892-09)
ndc11
1657189250
500 TABLET, FILM COATED in 1 CONTAINER (16571-892-50)

Annotations

UNII (FDA Substance ID)

ZOU145W1XL

FLUPHENAZINE HYDROCHLORIDE

RxCUI 203207

Orange Book

A218283

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": "16571-892_5e7076f6-426b-45c2-865f-7be79fe81205",
  "productndc": "16571-892",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218283",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jun 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Jun 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jun 7, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jun 7, 2024"
      }
    ],
    "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 Hydrochoride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218283",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluphenazine hydrochloride",
  "start_marketing_date": "20240607",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AB02.

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