ZELAPAR

Product NDC: 0187-0453
11-digit product format: 001870453
Labeler code: 0187
Product ID: 0187-0453_f8d8f532-d8a6-4eff-baab-325fed820cdb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SELEGILINE HYDROCHLORIDE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA021479
Marketing category: NDA
Marketing start: 2006-06-14
Marketing end: 2028-07-31
Substance: SELEGILINE HYDROCHLORIDE
Active strength: 1.25 mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0187-0453	0187-0453-03	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021479-001	ZELAPAR	SELEGILINE HYDROCHLORIDE	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2006-06-14

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021479-001	ZELAPAR	1.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-06-14	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: ZELAPAR

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEGILINE HYDROCHLORIDE	1.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6W731X367Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859190	Internal RxNorm lookup
859192	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
380d7717-2a79-42f3-a712-efe5e7696ba0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
6780a268-60d0-4c35-b9cf-cd4360ac8329	Product name	1	20190702
897f5455-61fe-1903-6c67-bd52e2f7ffbe	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
98710086-9ad6-ee93-d125-b72fb2fc859a	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0187-0453-02	ZELAPAR	10 in 1 POUCH	TABLET, ORALLY DISINTEGRATING	10	12
0187-0453-02	ZELAPAR	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6	12
0187-0453-03	ZELAPAR	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	12
0187-0453-03	ZELAPAR	10 in 1 POUCH	TABLET, ORALLY DISINTEGRATING	10	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0453-02	EA - Each	0187-0453	e2e98b8a-ae17-4a61-9bc1-4b959ef9f21c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SELEGILINE HYDROCHLORIDE	ACTIVE INGREDIENT	6W731X367Q	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
SELEGILINE	ACTIVE MOIETY	2K1V7GP655	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-0453	ZELAPAR (SELEGILINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [BAUSCH HEALTH US, LLC]	12	Current NDC, Legacy NDC, 4 package rows	20210831_380d7717-2a79-42f3-a712-efe5e7696ba0.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
ZELAPAR	SELEGILINE HYDROCHLORIDE	Bausch Health US, LLC	380d7717-2a79-42f3-a712-efe5e7696ba0	2021-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021479 application number: NDA021479 ndc (product): 0187-0453

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6W731X367Q	SELEGILINE HYDROCHLORIDE	14611-52-0	SELEGILINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859190	selegiline HCl 1.25 MG Disintegrating Oral Tablet	PSN	380d7717-2a79-42f3-a712-efe5e7696ba0	12
859192	Zelapar 1.25 MG Disintegrating Oral Tablet	PSN	380d7717-2a79-42f3-a712-efe5e7696ba0	12
859192	selegiline hydrochloride 1.25 MG Disintegrating Oral Tablet [Zelapar]	SBD	380d7717-2a79-42f3-a712-efe5e7696ba0	12
859190	selegiline hydrochloride 1.25 MG Disintegrating Oral Tablet	SCD	380d7717-2a79-42f3-a712-efe5e7696ba0	12
859192	Zelapar 1.25 MG Disintegrating Oral Tablet	SY	380d7717-2a79-42f3-a712-efe5e7696ba0	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0453-02	00187045302	6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH	6 pouch	2006-06-14	0000-00-00	No	No	Current
0187-0453-03	00187045303	1 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZELAPAR	Bausch Health US, LLC \| Catalent Pharma Solutions Limited	2021-06-01	HUMAN PRESCRIPTION DRUG LABEL	13