Trifluoperazine Hydrochloride

Orange BookUNIISPLATC N05AB06

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378240501
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2405-01)

Annotations

UNII (FDA Substance ID)

6P1Y2SNF5V

TRIFLUOPERAZINE HYDROCHLORIDE

RxCUI 91130

Orange Book

A040209

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6P1Y2SNF5V",
    "rxcui": "91130",
    "inchikey": "BXDAOUXDMHXPDI-UHFFFAOYSA-N",
    "display_name": "TRIFLUOPERAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8501543b-0c74-4087-9946-e7198400814a": {
      "match": "brand_token",
      "title": "TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH LLC]",
      "spl_version": "3",
      "published_date": "2026-05-06"
    }
  },
  "productid": "0378-2405_7586125c-d9c7-4c56-8ca8-8add657a91db",
  "productndc": "0378-2405",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "040209",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jul 7, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jul 7, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jul 7, 1997"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Jul 7, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIFLUOPERAZINE HYDROCHLORIDE",
  "proprietary_name": "Trifluoperazine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040209",
  "marketing_category": "ANDA",
  "nonproprietary_name": "trifluoperazine hydrochloride",
  "start_marketing_date": "19970829",
  "active_numerator_strength": "5"
}

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