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United States · US · US:70771-1584_1db40261-ae57-4539-a7e9-7ca75d96627a

Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

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

Packs · 2

  • ndc11
    7077115841
    100 TABLET, FILM COATED in 1 BOTTLE (70771-1584-1)
  • ndc11
    7077115845
    500 TABLET, FILM COATED in 1 BOTTLE (70771-1584-5)

Annotations

UNII (FDA Substance ID)
ZOU145W1XL
FLUPHENAZINE HYDROCHLORIDE
RxCUI 203207
Orange Book
A214552
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": "70771-1584_1db40261-ae57-4539-a7e9-7ca75d96627a",
  "productndc": "70771-1584",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214552",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "May 27, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "May 27, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "May 27, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "May 27, 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": "ANDA214552",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20210528",
  "active_numerator_strength": "10"
}

Related drugs

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