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United States · US · US:61748-054_3a17b358-46b6-4e74-9788-ccb8acf9ca8f

Trihexyphenidyl Hydrochloride

Orange BookUNIISPLATC N04AA01

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

Identification

ManufacturerAkorn
CountryUS (United States)
ATC codeN04AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6174805416
    473 mL in 1 BOTTLE, PLASTIC (61748-054-16)

Annotations

UNII (FDA Substance ID)
AO61G82577
TRIHEXYPHENIDYL HYDROCHLORIDE
RxCUI 1115
Orange Book
A040251
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "AO61G82577",
    "rxcui": "1115",
    "inchikey": "QDWJJTJNXAKQKD-UHFFFAOYSA-N",
    "display_name": "TRIHEXYPHENIDYL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b60ef86c-b8b6-4530-baaf-d4671ce961af": {
      "match": "brand_token",
      "title": "TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]",
      "spl_version": "12",
      "published_date": "2026-03-30"
    }
  },
  "productid": "61748-054_3a17b358-46b6-4e74-9788-ccb8acf9ca8f",
  "productndc": "61748-054",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "040251",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 27, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIHEXYPHENIDYL HYDROCHLORIDE",
  "proprietary_name": "Trihexyphenidyl Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA040251",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trihexyphenidyl Hydrochloride",
  "start_marketing_date": "20010301",
  "active_numerator_strength": "2"
}

Related drugs

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