Pramipexole Dihydrochloride

Product NDC: 57237-184
11-digit product format: 572370184
Labeler code: 57237
Product ID: 57237-184_967cfcd5-d04f-4637-a364-632bf7ca72b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202633
Marketing category: ANDA
Marketing start: 2012-10-26
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26
A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26
A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26
A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26
A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26
A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202633-001	AB
A202633-002	AB
A202633-003	AB
A202633-004	AB
A202633-005	AB
A202633-006	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 7 · 246 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	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A202633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pramipexole Dihydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	1 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858625	Internal RxNorm lookup
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
56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
3863aae0-7028-3427-389e-3f6c8692e587	Product name	3	20190117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-184-90	Pramipexole Dihydrochloride	90 in 1 BOTTLE	TABLET	90		11
57237-184-99	Pramipexole Dihydrochloride	1000 in 1 BOTTLE	TABLET	1000		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-184-90	EA - Each	57237-184	492cefca-2cb5-462c-9447-742a17da208a	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-184	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240222_56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	468830df-941c-4363-b432-94de9b7fd2ac	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Rising Pharma Holdings, Inc.	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633 ndc (product): 57237-184
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Aurobindo Pharma Limited	3f90971a-e005-4dd3-bb93-b09125ada3c8	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	29b639e3-25a5-4c2f-b4ea-a119db79fe0c	2024-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	7cd6a546-d516-427c-af79-555390ccd35b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633

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	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	PSN	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
858625	pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	11
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	4
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	4
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-184-90	57237018490	90 TABLET in 1 BOTTLE (57237-184-90)	90 tablet	2012-10-26	0000-00-00	No	No	Current
57237-184-99	57237018499	1000 TABLET in 1 BOTTLE (57237-184-99)	1000 tablet	2012-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Bryant Ranch Prepack	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	4
Pramipexole Dihydrochloride	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-12-11	Human Prescription Drug Label	11