SELEGILINE HYDROCHLORIDE

Product NDC: 60505-0055
11-digit product format: 605050055
Labeler code: 60505
Product ID: 60505-0055_926ca826-c932-dcf7-18b7-9df0e06eea6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SELEGILINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075321
Marketing category: ANDA
Marketing start: 1997-07-15
Substance: SELEGILINE HYDROCHLORIDE
Active strength: 5 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075321-001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075321-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075321-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RS	1998-12-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075321-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075321-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075321-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075321-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075321-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075321-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075321-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075321-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075321-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075321-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075321-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075321-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075321-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075321-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075321-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075321-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075321-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075321-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075321-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075321-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075321-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075321-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075321-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075321-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075321-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075321-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075321-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075321-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075321-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075321-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075321-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075321-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075321-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075321-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075321-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075321-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075321-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075321-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075321-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075321-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: SELEGILINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEGILINE HYDROCHLORIDE	5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
6780a268-60d0-4c35-b9cf-cd4360ac8329	Product name	1	20190702
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
60505-0055-1	SELEGILINE HYDROCHLORIDE	60 in 1 BOTTLE	CAPSULE	60	8
60505-0055-2	SELEGILINE HYDROCHLORIDE	1000 in 1 BOTTLE	CAPSULE	1000	8
60505-0055-3	SELEGILINE HYDROCHLORIDE	500 in 1 BOTTLE	CAPSULE	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0055-1	EA - Each	60505-0055	a037ebd9-1048-4870-82a9-f32dde5a7d04	1	2012-07-24
60505-0055-2	EA - Each	60505-0055	ab98d637-c295-434b-941d-081a45803cb6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SELEGILINE HYDROCHLORIDE	ACTIVE INGREDIENT	6W731X367Q	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
SELEGILINE	ACTIVE MOIETY	2K1V7GP655	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0055	SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]	7	Current NDC, Legacy NDC, 3 package rows	20241003_1924db3d-6a16-4496-cfd0-6903be146925.zip

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
859186	selegiline HCl 5 MG Oral Capsule	PSN	1924db3d-6a16-4496-cfd0-6903be146925	8
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	1924db3d-6a16-4496-cfd0-6903be146925	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0055-1	60505005501	60 CAPSULE in 1 BOTTLE (60505-0055-1)	60 capsule	1997-07-15	0000-00-00	No	No	Current
60505-0055-2	60505005502	1000 CAPSULE in 1 BOTTLE (60505-0055-2)	1000 capsule	1997-07-15	0000-00-00	No	No	Current
60505-0055-3	60505005503	500 CAPSULE in 1 BOTTLE (60505-0055-3)	500 capsule	1997-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Selegiline Hydrochloride Capsules, 5 mg	Apotex Corp. \| Apotex Inc.	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL	9