Selegiline Hydrochloride

Product NDC: 16571-659
11-digit product format: 165710659
Labeler code: 16571
Product ID: 16571-659_102210a0-2a43-44c4-aedf-7741b84675ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Selegiline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA206803
Marketing category: ANDA
Marketing start: 2019-04-02
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
A206803-001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB		2019-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206803-001	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	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206803-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	2019-04-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206803-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206803-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206803-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206803-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206803-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206803-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206803-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206803-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206803-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206803-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206803-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206803-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206803-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206803-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206803-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206803-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206803-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206803-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206803-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206803-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206803-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206803-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206803-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206803-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206803-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206803-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206803-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206803-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206803-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206803-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206803-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206803-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206803-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206803-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206803-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206803-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206803-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206803-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206803-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206803-001	AB	1	`cb3db0bc1861…`

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
23c4481f-d150-40c6-addb-b3e454ca914f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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	Strength	SPL version
16571-659-06	Selegiline Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		3
16571-659-50	Selegiline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-659-06	EA - Each	16571-659	8468740f-4202-4ec4-a7c4-12910fe7293b	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-659	SELEGILINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240809_23c4481f-d150-40c6-addb-b3e454ca914f.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	Bryant Ranch Prepack	4848270a-1179-410c-b4e6-a7e555b3a988	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206803 application number: ANDA206803
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	23c4481f-d150-40c6-addb-b3e454ca914f	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206803 application number: ANDA206803 ndc (product): 16571-659
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Proficient Rx LP	57b564ef-c89b-4cf6-a11f-f67391d74e7e	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206803 application number: ANDA206803

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	23c4481f-d150-40c6-addb-b3e454ca914f	3
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	23c4481f-d150-40c6-addb-b3e454ca914f	3
859186	selegiline HCl 5 MG Oral Capsule	PSN	57b564ef-c89b-4cf6-a11f-f67391d74e7e	2
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	57b564ef-c89b-4cf6-a11f-f67391d74e7e	2
859186	selegiline HCl 5 MG Oral Capsule	PSN	4848270a-1179-410c-b4e6-a7e555b3a988	1
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	4848270a-1179-410c-b4e6-a7e555b3a988	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-659-06	16571065906	60 CAPSULE in 1 BOTTLE (16571-659-06)	60 capsule	2019-04-02	0000-00-00	No	No	Current
16571-659-50	16571065950	500 CAPSULE in 1 BOTTLE (16571-659-50)	500 capsule	2019-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Selegiline Hydrochloride Capsules, 5 mg	Bryant Ranch Prepack	2025-07-15	HUMAN PRESCRIPTION DRUG LABEL	1
Selegiline Hydrochloride Capsules, 5 mg	Rising Pharma Holdings, Inc. \| Ingenus Pharmaceuticals NJ, LLC	2024-08-07	Human Prescription Drug Label	3
Selegiline Hydrochloride Capsules, 5mg	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2