FDA.reportPublic FDA data

NDC 49502-900-01 - EMSAM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49502-900
Requested NDC
49502-900-01
Package NDCs from labels
49502-900-01, 49502-900-30, 49502-900-11, 49502-900-05
Manufacturer
Viatris Specialty LLC
Effective date
2020-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EMSAM - Viatris Specialty LLCViatris Specialty LLC2020-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-900-01EMSAM1 in 1 POUCHPATCH117
49502-900-01EMSAM24 h in 1 PATCHPATCH2417
49502-900-05EMSAM5 in 1 CARTONPATCH517
49502-900-11EMSAM1 in 1 POUCHPATCH117
49502-900-11EMSAM24 h in 1 PATCHPATCH2417
49502-900-30EMSAM30 in 1 CARTONPATCH3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-900EMSAM (SELEGILINE) PATCH [VIATRIS SPECIALTY LLC]17Current NDC, Legacy NDC, 6 package rows20250210_b891bd9f-fdb8-4862-89c5-ecdd700398a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-900-01EA - Each49502-9005619ff08-c9d5-4e61-bd03-8d64d82fdef512016-03-04
49502-900-30EA - Each49502-900b7bd93c5-6817-42a3-b7bd-d60be32f92d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELEGILINEACTIVE INGREDIENT2K1V7GP655EMSAM (SELEGILINE) PATCH [MYLAN SPECIALTY]10
SELEGILINEACTIVE MOIETY2K1V7GP655EMSAM (SELEGILINE) PATCH [MYLAN SPECIALTY]10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMSAMSELEGILINEViatris Specialty LLCb891bd9f-fdb8-4862-89c5-ecdd700398a32020-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021336
ndc (package): 49502-902-01
ndc (package): 49502-900-05
ndc (package): 49502-901-30
ndc (package): 49502-900-01
ndc (package): 49502-901-01
ndc (package): 49502-900-30
ndc (package): 49502-902-30
ndc (package): 49502-900-11
ndc (product): 49502-901
ndc (product): 49502-902
ndc (product): 49502-900
ndc11 (package): 49502090001
rxcui: 865210
rxcui: 865216
rxcui: 865208
rxcui: 865214
rxcui: 865212
rxcui: 865206
spl id: 97cc8813-9de7-42f5-89dd-c46f8b6730fa
spl set id: b891bd9f-fdb8-4862-89c5-ecdd700398a3
unii: 2K1V7GP655

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.