Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

ManufacturerUpsher-Smith Laboratories,LLC

CountryUS (United States)

ATC codeN05AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0832600411
100 TABLET, FILM COATED in 1 BOTTLE (0832-6004-11)

Annotations

UNII (FDA Substance ID)

ZOU145W1XL

FLUPHENAZINE HYDROCHLORIDE

RxCUI 203207

Orange Book

A213784

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": "0832-6004_3bb74f82-8872-9829-e063-6294a90aeace",
  "productndc": "0832-6004",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213784",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Oct 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Oct 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Oct 24, 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": "ANDA213784",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20221122",
  "active_numerator_strength": "2.5"
}

Related drugs

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