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United States · US · US:49502-902_97cc8813-9de7-42f5-89dd-c46f8b6730fa
EMSAM
Orange BookUNIISPLATC N04BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN04BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11495029023030 POUCH in 1 CARTON (49502-902-30) / 1 PATCH in 1 POUCH (49502-902-01) / 24 h in 1 PATCH
Annotations
UNII (FDA Substance ID)
2K1V7GP655
SELEGILINE
RxCUI 9639
Orange Book
N021336
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2K1V7GP655",
"rxcui": "9639",
"inchikey": "MEZLKOACVSPNER-GFCCVEGCSA-N",
"display_name": "SELEGILINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"b891bd9f-fdb8-4862-89c5-ecdd700398a3": {
"match": "brand_token",
"title": "EMSAM (SELEGILINE) PATCH [VIATRIS SPECIALTY LLC]",
"spl_version": "17",
"published_date": "2025-02-10"
}
},
"productid": "49502-902_97cc8813-9de7-42f5-89dd-c46f8b6730fa",
"productndc": "49502-902",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "021336",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "6MG/24HR",
"product_no": "001",
"approval_date": "Feb 27, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG/24HR",
"product_no": "002",
"approval_date": "Feb 27, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "12MG/24HR",
"product_no": "003",
"approval_date": "Feb 27, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SELEGILINE",
"proprietary_name": "EMSAM",
"active_ingred_unit": "mg/24h",
"application_number": "NDA021336",
"marketing_category": "NDA",
"nonproprietary_name": "selegiline",
"start_marketing_date": "20060227",
"active_numerator_strength": "12"
}Related drugs
Other records sharing ATC code N04BD01.
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