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United States · US · US:43386-660_49c03212-c2eb-49b8-bc11-bbfd75122965

Trimethobenzamide Hydrochloride

Orange BookUNIISPLATC R06AA10

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeR06AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4338666003
    30 CAPSULE in 1 BOTTLE (43386-660-03)
  • ndc11
    4338666024
    100 CAPSULE in 1 BOTTLE (43386-660-24)

Annotations

UNII (FDA Substance ID)
WDQ5P1SX7Q
TRIMETHOBENZAMIDE HYDROCHLORIDE
RxCUI 57227
Orange Book
A076546
AB
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": "ORAL",
  "spl_meta": {
    "ee626da9-cffc-4bb9-a528-482687201b2a": {
      "match": "brand_token",
      "title": "TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC]",
      "spl_version": "2",
      "published_date": "2025-12-12"
    }
  },
  "productid": "43386-660_49c03212-c2eb-49b8-bc11-bbfd75122965",
  "productndc": "43386-660",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076546",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Aug 20, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIMETHOBENZAMIDE HYDROCHLORIDE",
  "proprietary_name": "Trimethobenzamide Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076546",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trimethobenzamide Hydrochloride",
  "start_marketing_date": "20110117",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code R06AA10.

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