TRIHEXYPHENIDYL HYDROCHLORIDE

Orange BookUNIISPLATC N04AA01

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

Identification

ManufacturerNovitium Pharma LLC

CountryUS (United States)

ATC codeN04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7095421210
100 TABLET in 1 BOTTLE (70954-212-10)
ndc11
7095421220
1000 TABLET in 1 BOTTLE (70954-212-20)

Annotations

UNII (FDA Substance ID)

AO61G82577

TRIHEXYPHENIDYL HYDROCHLORIDE

RxCUI 1115

Orange Book

A040254

AAAA

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": "70954-212_83608c13-509d-448b-8559-5f5e8a9a0d75",
  "productndc": "70954-212",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040254",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Dec 24, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIHEXYPHENIDYL HYDROCHLORIDE",
  "proprietary_name": "TRIHEXYPHENIDYL HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040254",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRIHEXYPHENIDYL HYDROCHLORIDE",
  "start_marketing_date": "20190128",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N04AA01.

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