emsam

Generic: selegiline

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name emsam
Generic Name selegiline
Labeler viatris specialty llc
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

selegiline 9 mg/24h

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-901
Product ID 49502-901_97cc8813-9de7-42f5-89dd-c46f8b6730fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021336
Listing Expiration 2026-12-31
Marketing Start 2006-02-27

Pharmacologic Class

Established (EPC)
monoamine oxidase inhibitor [epc] monoamine oxidase type b inhibitor [epc]
Mechanism of Action
monoamine oxidase inhibitors [moa] monoamine oxidase-b inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502901
Hyphenated Format 49502-901

Supplemental Identifiers

RxCUI
865206 865208 865210 865212 865214 865216
UNII
2K1V7GP655
NUI
N0000175744 N0000000184 N0000175762 N0000175761

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 emsam (source: ndc)
Generic Name selegiline (source: ndc)
Application Number NDA021336 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/24h
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH
source: ndc

Packages (1)

49502-901-30 30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH

Ingredients (1)

selegiline (9 mg/24h)

Linked Drug Pages (1)

EMSAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "97cc8813-9de7-42f5-89dd-c46f8b6730fa", "openfda": {"nui": ["N0000175744", "N0000000184", "N0000175762", "N0000175761"], "unii": ["2K1V7GP655"], "rxcui": ["865206", "865208", "865210", "865212", "865214", "865216"], "spl_set_id": ["b891bd9f-fdb8-4862-89c5-ecdd700398a3"], "pharm_class_epc": ["Monoamine Oxidase Inhibitor [EPC]", "Monoamine Oxidase Type B Inhibitor [EPC]"], "pharm_class_moa": ["Monoamine Oxidase Inhibitors [MoA]", "Monoamine Oxidase-B Inhibitors [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (49502-901-30)  / 1 PATCH in 1 POUCH (49502-901-01)  / 24 h in 1 PATCH", "package_ndc": "49502-901-30", "marketing_start_date": "20060227"}], "brand_name": "EMSAM", "product_id": "49502-901_97cc8813-9de7-42f5-89dd-c46f8b6730fa", "dosage_form": "PATCH", "pharm_class": ["Monoamine Oxidase Inhibitor [EPC]", "Monoamine Oxidase Inhibitors [MoA]", "Monoamine Oxidase Type B Inhibitor [EPC]", "Monoamine Oxidase-B Inhibitors [MoA]"], "product_ndc": "49502-901", "generic_name": "selegiline", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMSAM", "active_ingredients": [{"name": "SELEGILINE", "strength": "9 mg/24h"}], "application_number": "NDA021336", "marketing_category": "NDA", "marketing_start_date": "20060227", "listing_expiration_date": "20261231"}