Selegiline Hydrochloride

Product NDC: 70954-504
11-digit product format: 709540504
Labeler code: 70954
Product ID: 70954-504_e42d99b0-c62e-49d4-b792-1301bb539b92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Selegiline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Novitium Pharma LLC
Application: ANDA075352
Marketing category: ANDA
Marketing start: 2021-04-01
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075352-001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB		1998-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075352-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075352-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075352-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075352-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075352-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075352-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075352-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075352-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075352-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075352-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075352-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075352-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075352-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075352-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075352-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A075352-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075352-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075352-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075352-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEGILINE HYDROCHLORIDE	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859186	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
e42d99b0-c62e-49d4-b792-1301bb539b92	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	Strength	SPL version
70954-504-10	Selegiline Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		1
70954-504-20	Selegiline Hydrochloride	1000 in 1 BOTTLE	CAPSULE	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-504-10	EA - Each	70954-504	23535d19-8107-4bd0-867d-f2b7528a46c2	1	2021-05-05
70954-504-20	EA - Each	70954-504	bffd5776-d47b-4f8e-8a80-47188ab9b6c9	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-504	SELEGILINE HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC]	1	Current NDC, Legacy NDC, 2 package rows	20210403_e42d99b0-c62e-49d4-b792-1301bb539b92.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	df88d6bf-0fda-3825-e053-2a95a90a3a75	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Bryant Ranch Prepack	b8eb0a00-adc7-4aaf-987c-fa1b207b2996	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Novitium Pharma LLC	e42d99b0-c62e-49d4-b792-1301bb539b92	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352 ndc (product): 70954-504

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	df88d6bf-0fda-3825-e053-2a95a90a3a75	4
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	df88d6bf-0fda-3825-e053-2a95a90a3a75	4
859186	selegiline HCl 5 MG Oral Capsule	PSN	b8eb0a00-adc7-4aaf-987c-fa1b207b2996	1
859186	selegiline HCl 5 MG Oral Capsule	PSN	e42d99b0-c62e-49d4-b792-1301bb539b92	1
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	b8eb0a00-adc7-4aaf-987c-fa1b207b2996	1
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	e42d99b0-c62e-49d4-b792-1301bb539b92	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-504-10	70954050410	60 CAPSULE in 1 BOTTLE (70954-504-10)	60 capsule	2021-04-01	0000-00-00	No	No	Current
70954-504-20	70954050420	1000 CAPSULE in 1 BOTTLE (70954-504-20)	1000 capsule	2021-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Selegiline Hydrochloride Capsules, USP Rx only	Marlex Pharmaceuticals, Inc.	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	4
Selegiline Hydrochloride Capsules, USP Rx only	Bryant Ranch Prepack	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	1
Selegiline Hydrochloride Capsules, USP Rx only	Novitium Pharma LLC	2021-04-01	Human Prescription Drug Label	1