selegiline hydrochloride

Generic: selegiline hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name selegiline hydrochloride
Generic Name selegiline hydrochloride
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

selegiline hydrochloride 5 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3438
Product ID 60505-3438_1f213cd2-ca80-aa07-6f27-a5093d23da13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074871
Listing Expiration 2026-12-31
Marketing Start 1997-07-06

Pharmacologic Class

Classes
monoamine oxidase inhibitor [epc] monoamine oxidase inhibitors [moa] monoamine oxidase type b inhibitor [epc] monoamine oxidase-b inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053438
Hyphenated Format 60505-3438

Supplemental Identifiers

RxCUI
859193
UPC
0360505343836
UNII
6W731X367Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name selegiline hydrochloride (source: ndc)
Generic Name selegiline hydrochloride (source: ndc)
Application Number ANDA074871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (60505-3438-3)
  • 500 TABLET in 1 BOTTLE (60505-3438-8)
source: ndc

Packages (2)

60505-3438-3 60 TABLET in 1 BOTTLE (60505-3438-3) 60505-3438-8 500 TABLET in 1 BOTTLE (60505-3438-8)

Ingredients (1)

selegiline hydrochloride (5 mg/1)

Linked Drug Pages (1)

Selegiline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f213cd2-ca80-aa07-6f27-a5093d23da13", "openfda": {"upc": ["0360505343836"], "unii": ["6W731X367Q"], "rxcui": ["859193"], "spl_set_id": ["2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (60505-3438-3)", "package_ndc": "60505-3438-3", "marketing_start_date": "19970706"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (60505-3438-8)", "package_ndc": "60505-3438-8", "marketing_start_date": "19970706"}], "brand_name": "Selegiline Hydrochloride", "product_id": "60505-3438_1f213cd2-ca80-aa07-6f27-a5093d23da13", "dosage_form": "TABLET", "pharm_class": ["Monoamine Oxidase Inhibitor [EPC]", "Monoamine Oxidase Inhibitors [MoA]", "Monoamine Oxidase Type B Inhibitor [EPC]", "Monoamine Oxidase-B Inhibitors [MoA]"], "product_ndc": "60505-3438", "generic_name": "Selegiline Hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Selegiline Hydrochloride", "active_ingredients": [{"name": "SELEGILINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA074871", "marketing_category": "ANDA", "marketing_start_date": "19970706", "listing_expiration_date": "20261231"}