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United States · US · US:60505-0055_2a0cd745-7f62-19e1-d623-fea131789df0

SELEGILINE HYDROCHLORIDE

Orange BookUNIISPLATC N04BD01

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN04BD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6050500551
    60 CAPSULE in 1 BOTTLE (60505-0055-1)
  • ndc11
    6050500552
    1000 CAPSULE in 1 BOTTLE (60505-0055-2)
  • ndc11
    6050500553
    500 CAPSULE in 1 BOTTLE (60505-0055-3)

Annotations

UNII (FDA Substance ID)
6W731X367Q
SELEGILINE HYDROCHLORIDE
RxCUI 203137
Orange Book
A075321
AB
DailyMed SPL labels
1 version tracked
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",
  "spl_meta": {
    "040a97e5-efd1-4a2f-b737-2f13e5366d70": {
      "match": "brand_token",
      "title": "SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "10",
      "published_date": "2025-12-08"
    }
  },
  "productid": "60505-0055_2a0cd745-7f62-19e1-d623-fea131789df0",
  "productndc": "60505-0055",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075321",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 4, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELEGILINE HYDROCHLORIDE",
  "proprietary_name": "SELEGILINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075321",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SELEGILINE HYDROCHLORIDE",
  "start_marketing_date": "19970715",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N04BD01.

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