Pramipexole Dihydrochloride

Product NDC: 0615-7597
11-digit product format: 006157597
Labeler code: 0615
Product ID: 0615-7597_9a8d5c03-8596-491b-8cc0-89b7acfdfca5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA077724
Marketing category: ANDA
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-7597		D	Discontinued by firm		2026-08-17
excluded package	package	0615-7597	0615-7597-39	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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7597-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7597-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7597-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7597-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7597-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7597-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7597-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7597-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7597-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7597-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7597-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7597-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0615-7597-39	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0615-7597-39	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0615-7597-39	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0615-7597-39	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7597-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7597-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7597-39	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19
A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19
A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19
A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19
A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19

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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077724-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2008-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077724-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2008-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077724-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2008-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077724-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2008-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077724-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2008-02-19	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077724-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077724-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077724-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077724-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077724-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077724-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077724-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077724-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077724-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077724-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077724-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077724-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077724-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077724-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077724-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077724-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077724-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077724-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077724-005	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7597-39	2022-11-09	C162847	48780-1	960f7f55-bfde-8e05-e053-dbdaa90a074a	PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg Tablets
0615-7597-39	2019-10-29	C162847	48780-1	960f7f55-bfde-8e05-e053-dbdaa90a074a	PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg Tablets

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE	191217-81-9	PRAMIPEXOLE DIHYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg Tablets	NCS HealthCare of KY, Inc dba Vangard Labs	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1