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United States · US · US:68083-476_8475631f-7d35-47e8-9b93-26357f757277

fluphenazine decanoate

In shortageOrange BookUNIISPLATC N05AB02

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

Identification

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

Packs · 1

  • ndc11
    6808347601
    1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
FMU62K1L3C
FLUPHENAZINE DECANOATE
RxCUI 25190
Orange Book
A215509
AO
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluphenazine Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "FMU62K1L3C",
    "rxcui": "25190",
    "inchikey": "VIQCGTZFEYDQMR-UHFFFAOYSA-N",
    "display_name": "FLUPHENAZINE DECANOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; SUBCUTANEOUS",
  "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": "68083-476_8475631f-7d35-47e8-9b93-26357f757277",
  "productndc": "68083-476",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215509",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Mar 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUPHENAZINE DECANOATE",
  "shortage_reason": "Fluphenazine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "fluphenazine decanoate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215509",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluphenazine decanoate",
  "start_marketing_date": "20230330",
  "active_numerator_strength": "25"
}

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