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United States · US · US:0187-0453_f8d8f532-d8a6-4eff-baab-325fed820cdb

ZELAPAR

Orange BookUNIIATC N04BD01

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeN04BD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0187045302
    6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH

Annotations

UNII (FDA Substance ID)
6W731X367Q
SELEGILINE HYDROCHLORIDE
RxCUI 203137
Orange Book
N021479
Raw payload (JSON)
{
  "unii": {
    "unii": "6W731X367Q",
    "rxcui": "203137",
    "inchikey": "IYETZZCWLLUHIJ-UTONKHPSSA-N",
    "display_name": "SELEGILINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "0187-0453_f8d8f532-d8a6-4eff-baab-325fed820cdb",
  "productndc": "0187-0453",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "021479",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.25MG",
        "product_no": "001",
        "approval_date": "Jun 14, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELEGILINE HYDROCHLORIDE",
  "proprietary_name": "ZELAPAR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021479",
  "marketing_category": "NDA",
  "nonproprietary_name": "SELEGILINE HYDROCHLORIDE",
  "start_marketing_date": "20060614",
  "active_numerator_strength": "1.25"
}

Related drugs

Other records sharing ATC code N04BD01.

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