Pramipexole Dihydrochloride

Product NDC: 0781-5248
11-digit product format: 007815248
Labeler code: 0781
Product ID: 0781-5248_57121d70-d083-4862-b4e5-c69e12067089
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA090190
Marketing category: ANDA
Marketing start: 2010-07-06
Marketing end: 0000-00-00
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5248		D	Discontinued by firm	2026-08-17
excluded package	package	0781-5248	0781-5248-13	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5248	0781-5248-92	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 · 45 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	0781-5248-13	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5248-92	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	0781-5248-13	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5248-92	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	0781-5248-92	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0781-5248-13	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	0781-5248-92	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-5248-13	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0781-5248-92	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0781-5248-13	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06
A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06
A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06
A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06
A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06
A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08

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 7 · 252 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	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0781-5248-13	2021-04-09	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
0781-5248-92	2021-04-09	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
0781-5248-13	2020-01-31	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
0781-5248-92	2020-01-31	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5248-92	EA - Each	0781-5248	4a1a53f8-0e44-4149-b9b5-5abb23641e10	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [SANDOZ INC]	11