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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021336-001	EMSAM	SELEGILINE	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27
N021336-002	EMSAM	SELEGILINE	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27
N021336-003	EMSAM	SELEGILINE	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021336-002	EMSAM	9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021336-003	EMSAM	12MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2006-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021336-001	EMSAM	6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2006-02-27	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEGILINE	9 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2K1V7GP655	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
865206	Internal RxNorm lookup
865208	Internal RxNorm lookup
865210	Internal RxNorm lookup
865212	Internal RxNorm lookup
865214	Internal RxNorm lookup
865216	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b891bd9f-fdb8-4862-89c5-ecdd700398a3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6780a268-60d0-4c35-b9cf-cd4360ac8329	Product name	1	20190702
897f5455-61fe-1903-6c67-bd52e2f7ffbe	Product name	1	20140508
98710086-9ad6-ee93-d125-b72fb2fc859a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49502-901-01	EMSAM	1 in 1 POUCH	PATCH	1	17
49502-901-01	EMSAM	24 h in 1 PATCH	PATCH	24	17
49502-901-30	EMSAM	30 in 1 CARTON	PATCH	30	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-901-01	EA - Each	49502-901	6827a6d7-ae1f-43b6-8f88-875e8a89c9f7	1	2015-08-04
49502-901-30	EA - Each	49502-901	79090b4c-441b-4ff3-b92f-383b1ad2d2c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
SELEGILINE	ACTIVE INGREDIENT	2K1V7GP655	EMSAM (SELEGILINE) PATCH [MYLAN SPECIALTY]	10
SELEGILINE	ACTIVE MOIETY	2K1V7GP655	EMSAM (SELEGILINE) PATCH [MYLAN SPECIALTY]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-901	EMSAM (SELEGILINE) PATCH [VIATRIS SPECIALTY LLC]	17	Current NDC, Legacy NDC, 3 package rows	20250210_b891bd9f-fdb8-4862-89c5-ecdd700398a3.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EMSAM	SELEGILINE	Viatris Specialty LLC	b891bd9f-fdb8-4862-89c5-ecdd700398a3	2020-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021336 application number: NDA021336 ndc (product): 49502-901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2K1V7GP655	SELEGILINE	14611-51-9	SELEGILINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
865216	EMSAM 12 MG/Day 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865208	EMSAM 6 MG/Day 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865212	EMSAM 9 MG/Day 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865214	selegiline 12 MG/Day 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865206	selegiline 6 MG/Day 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865210	selegiline 9 MG/HR 24HR Transdermal System	PSN	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865208	24 HR selegiline 0.25 MG/HR Transdermal System [Emsam]	SBD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865212	24 HR selegiline 0.375 MG/HR Transdermal System [Emsam]	SBD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865216	24 HR selegiline 0.5 MG/HR Transdermal System [Emsam]	SBD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865206	24 HR selegiline 0.25 MG/HR Transdermal System	SCD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865210	24 HR selegiline 0.375 MG/HR Transdermal System	SCD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865214	24 HR selegiline 0.5 MG/HR Transdermal System	SCD	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865208	24 HR Emsam 0.25 MG/HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865212	24 HR Emsam 0.375 MG/HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865216	24 HR Emsam 0.5 MG/HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865216	Emsam 12 MG per 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865216	EMSAM 12 MG/Day 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865208	Emsam 6 MG per 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865208	EMSAM 6 MG/Day 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865212	Emsam 9 MG per 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865212	EMSAM 9 MG/Day 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865206	selegiline 0.25 MG/HR 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865210	selegiline 0.375 MG/HR 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865214	selegiline 0.5 MG/HR 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865214	selegiline 12 MG/Day 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865214	selegiline 12 MG/Day 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865206	selegiline 6 MG/Day 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865206	selegiline 6 MG/Day 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865210	selegiline 9 MG/Day 24 HR Transdermal Patch	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17
865210	selegiline 9 MG/HR 24HR Transdermal System	SY	b891bd9f-fdb8-4862-89c5-ecdd700398a3	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-901-01	49502090101	1 in 1 POUCH						Historical
49502-901-30	49502090130	30 POUCH in 1 CARTON (49502-901-30) / 1 PATCH in 1 POUCH (49502-901-01) / 24 h in 1 PATCH	30 pouch	2006-02-27	0000-00-00	No	No	Current