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United States · US · US:42023-119_1ff4d082-abae-4412-818b-099c8a1e4ede

Tigan

Orange BookUNIISPLATC R06AA10

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

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeR06AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4202311925
    25 VIAL, SINGLE-DOSE in 1 TRAY (42023-119-25) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
WDQ5P1SX7Q
TRIMETHOBENZAMIDE HYDROCHLORIDE
RxCUI 57227
Orange Book
N017530
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WDQ5P1SX7Q",
    "rxcui": "57227",
    "inchikey": "WIIZEEPFHXAUND-UHFFFAOYSA-N",
    "display_name": "TRIMETHOBENZAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "7da90678-b229-4ad6-9193-2b8a3e9ba695": {
      "match": "brand_token",
      "title": "TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "13",
      "published_date": "2026-05-21"
    }
  },
  "productid": "42023-119_1ff4d082-abae-4412-818b-099c8a1e4ede",
  "productndc": "42023-119",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "017530",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIMETHOBENZAMIDE HYDROCHLORIDE",
  "proprietary_name": "Tigan",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017530",
  "marketing_category": "NDA",
  "nonproprietary_name": "trimethobenzamide hydrochloride",
  "start_marketing_date": "20080801",
  "active_numerator_strength": "100"
}

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