selegiline hydrochloride

Generic: selegiline hydrochloride

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name selegiline hydrochloride
Generic Name selegiline hydrochloride
Labeler novitium pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

selegiline hydrochloride 5 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-504
Product ID 70954-504_e42d99b0-c62e-49d4-b792-1301bb539b92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075352
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

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 70954504
Hyphenated Format 70954-504

Supplemental Identifiers

RxCUI
859186
UPC
0370954504207 0370954504108
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 ANDA075352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (70954-504-10)
  • 1000 CAPSULE in 1 BOTTLE (70954-504-20)
source: ndc

Packages (2)

70954-504-10 60 CAPSULE in 1 BOTTLE (70954-504-10) 70954-504-20 1000 CAPSULE in 1 BOTTLE (70954-504-20)

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": "e42d99b0-c62e-49d4-b792-1301bb539b92", "openfda": {"upc": ["0370954504207", "0370954504108"], "unii": ["6W731X367Q"], "rxcui": ["859186"], "spl_set_id": ["e42d99b0-c62e-49d4-b792-1301bb539b92"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (70954-504-10)", "package_ndc": "70954-504-10", "marketing_start_date": "20210401"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (70954-504-20)", "package_ndc": "70954-504-20", "marketing_start_date": "20210401"}], "brand_name": "Selegiline Hydrochloride", "product_id": "70954-504_e42d99b0-c62e-49d4-b792-1301bb539b92", "dosage_form": "CAPSULE", "pharm_class": ["Monoamine Oxidase Inhibitor [EPC]", "Monoamine Oxidase Inhibitors [MoA]", "Monoamine Oxidase Type B Inhibitor [EPC]", "Monoamine Oxidase-B Inhibitors [MoA]"], "product_ndc": "70954-504", "generic_name": "Selegiline Hydrochloride", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Selegiline Hydrochloride", "active_ingredients": [{"name": "SELEGILINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA075352", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}