Pramipexole Dihydrochloride

Product NDC: 46708-005
11-digit product format: 467080005
Labeler code: 46708
Product ID: 46708-005_92f6ef1e-3256-45a7-a409-80dd85e95187
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA078894
Marketing category: ANDA
Marketing start: 2016-03-22
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: .5 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
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 43.

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
A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08
A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08
A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08
A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08
A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`

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	A078894-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-005	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A078894-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078894-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078894-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078894-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-005	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pramipexole Dihydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3D867NP06J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859033	Internal RxNorm lookup
859040	Internal RxNorm lookup
859044	Internal RxNorm lookup
859048	Internal RxNorm lookup
859052	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
92f6ef1e-3256-45a7-a409-80dd85e95187	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a67b8488-0225-64b1-be81-5cbe60d285a5	Product name	9	20221116
3863aae0-7028-3427-389e-3f6c8692e587	Product name	3	20190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-005-90	Pramipexole Dihydrochloride	90 in 1 BOTTLE	TABLET	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-005	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, Legacy NDC, 1 package rows	20171218_92f6ef1e-3256-45a7-a409-80dd85e95187.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
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	0a3ed933-ef5b-4091-8ae9-5768ae18514f	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	92f6ef1e-3256-45a7-a409-80dd85e95187	2017-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894 ndc (product): 46708-005

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	PSN	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	92f6ef1e-3256-45a7-a409-80dd85e95187	1
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	92f6ef1e-3256-45a7-a409-80dd85e95187	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-005-90	46708000590	90 TABLET in 1 BOTTLE (46708-005-90)	90 tablet	2016-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited \| Alembic Pharmaceutical Limited (Formulation Division)	2017-11-20	Human Prescription Drug Label	1