Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN05AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051846730
100 POUCH in 1 BOX (70518-4673-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4673-1)

Annotations

UNII (FDA Substance ID)

ZOU145W1XL

FLUPHENAZINE HYDROCHLORIDE

RxCUI 203207

Orange Book

A215674

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": "70518-4673_5331667a-ce7c-ffd3-e063-6294a90ac62a",
  "productndc": "70518-4673",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215674",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Apr 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Apr 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Apr 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Apr 14, 2022"
      }
    ],
    "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": "ANDA215674",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20260527",
  "active_numerator_strength": "10"
}

Related drugs

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