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United States · US · US:70954-273_b62e66ce-9c80-46f1-bb86-68f7f73c487c

Fluphenazine Hydrochloride

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095427310
    100 TABLET in 1 BOTTLE (70954-273-10)

Annotations

UNII (FDA Substance ID)
ZOU145W1XL
FLUPHENAZINE HYDROCHLORIDE
RxCUI 203207
Orange Book
A214674
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": "70954-273_b62e66ce-9c80-46f1-bb86-68f7f73c487c",
  "productndc": "70954-273",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214674",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Mar 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Mar 1, 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": "ANDA214674",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluphenazine Hydrochloride",
  "start_marketing_date": "20210301",
  "active_numerator_strength": "1"
}

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