FDA.reportPublic FDA data

EMSAM

Product NDC
49502-901
11-digit product format
495020901
Labeler code
49502
Product ID
49502-901_97cc8813-9de7-42f5-89dd-c46f8b6730fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
selegiline
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Viatris Specialty LLC
Application
NDA021336
Marketing category
NDA
Marketing start
2006-02-27
Substance
SELEGILINE
Active strength
9 mg/24h
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EMSAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEGILINE9 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2K1V7GP655
Rxcui865206, 865208, 865210, 865212, 865214, 865216

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-901-01EMSAM1 in 1 POUCHPATCH117
49502-901-01EMSAM24 h in 1 PATCHPATCH2417
49502-901-30EMSAM30 in 1 CARTONPATCH3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-901-01EA - Each49502-9016827a6d7-ae1f-43b6-8f88-875e8a89c9f712015-08-04
49502-901-30EA - Each49502-90179090b4c-441b-4ff3-b92f-383b1ad2d2c112012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-901EMSAM (SELEGILINE) PATCH [VIATRIS SPECIALTY LLC]17Current NDC, Legacy NDC, 3 package rows20250210_b891bd9f-fdb8-4862-89c5-ecdd700398a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865216EMSAM 12 MG/Day 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
865208EMSAM 6 MG/Day 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
865212EMSAM 9 MG/Day 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
865214selegiline 12 MG/Day 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
865206selegiline 6 MG/Day 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
865210selegiline 9 MG/HR 24HR Transdermal SystemPSNb891bd9f-fdb8-4862-89c5-ecdd700398a317
86520824 HR selegiline 0.25 MG/HR Transdermal System [Emsam]SBDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521224 HR selegiline 0.375 MG/HR Transdermal System [Emsam]SBDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521624 HR selegiline 0.5 MG/HR Transdermal System [Emsam]SBDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86520624 HR selegiline 0.25 MG/HR Transdermal SystemSCDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521024 HR selegiline 0.375 MG/HR Transdermal SystemSCDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521424 HR selegiline 0.5 MG/HR Transdermal SystemSCDb891bd9f-fdb8-4862-89c5-ecdd700398a317
86520824 HR Emsam 0.25 MG/HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521224 HR Emsam 0.375 MG/HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
86521624 HR Emsam 0.5 MG/HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865216Emsam 12 MG per 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865216EMSAM 12 MG/Day 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865208Emsam 6 MG per 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865208EMSAM 6 MG/Day 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865212Emsam 9 MG per 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865212EMSAM 9 MG/Day 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865206selegiline 0.25 MG/HR 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865210selegiline 0.375 MG/HR 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865214selegiline 0.5 MG/HR 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865214selegiline 12 MG/Day 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865214selegiline 12 MG/Day 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865206selegiline 6 MG/Day 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865206selegiline 6 MG/Day 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865210selegiline 9 MG/Day 24 HR Transdermal PatchSYb891bd9f-fdb8-4862-89c5-ecdd700398a317
865210selegiline 9 MG/HR 24HR Transdermal SystemSYb891bd9f-fdb8-4862-89c5-ecdd700398a317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-901-01495020901011 in 1 POUCHHistorical
49502-901-304950209013030 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH30 pouch2006-02-270000-00-00NoNoCurrent