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United States · US · US:0591-5335_0b42f7c5-1597-46fd-bc35-5f9286d27877

Trihexyphenidyl Hydrochloride

Orange BookUNIISPLATC N04AA01

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN04AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0591533501
    100 TABLET in 1 BOTTLE, PLASTIC (0591-5335-01)
  • ndc11
    0591533510
    1000 TABLET in 1 BOTTLE, PLASTIC (0591-5335-10)

Annotations

UNII (FDA Substance ID)
AO61G82577
TRIHEXYPHENIDYL HYDROCHLORIDE
RxCUI 1115
Orange Book
A084363
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": "0591-5335_0b42f7c5-1597-46fd-bc35-5f9286d27877",
  "productndc": "0591-5335",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "084363",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "ANDA084363",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trihexyphenidyl Hydrochloride",
  "start_marketing_date": "19871101",
  "active_numerator_strength": "2"
}

Related drugs

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