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United States · US · US:48433-143_51015912-4104-ed2c-e063-6294a90ab288

Trifluoperazine Hydrochloride

Orange BookUNIISPLATC N05AB06

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

Identification

ManufacturerSafecor Health LLC
CountryUS (United States)
ATC codeN05AB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4843314320
    100 BLISTER PACK in 1 CARTON (48433-143-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-143-01)

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": "48433-143_51015912-4104-ed2c-e063-6294a90ab288",
  "productndc": "48433-143",
  "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": "20260407",
  "active_numerator_strength": "10"
}

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