Pramipexole dihydrochloride

Product NDC: 68462-333
11-digit product format: 684620333
Labeler code: 68462
Product ID: 68462-333_75644134-fcad-4dde-8a22-453d18472002
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090781
Marketing category: ANDA
Marketing start: 2010-10-08
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1 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 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	RLD / RS	Approval date
A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08
A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08
A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08
A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08
A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08
A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090781-001	AB
A090781-002	AB
A090781-003	AB
A090781-004	AB
A090781-005	AB
A090781-006	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`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	A090781-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090781-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090781-004	AB	1	`2680178bc6a6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	44c336d2-01d1-4f13-bad9-549cdc3505ec	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090781 application number: ANDA090781 ndc (product): 68462-333
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5e6f2187-a5cc-481e-b0a1-d38d3f92e822	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090781 application number: ANDA090781

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	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
44c336d2-01d1-4f13-bad9-549cdc3505ec	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	SPL version
68462-333-05	Pramipexole dihydrochloride	500 in 1 BOTTLE	TABLET	500	13
68462-333-11	Pramipexole dihydrochloride	10 in 1 BLISTER PACK	TABLET	10	13
68462-333-11	Pramipexole dihydrochloride	10 in 1 CARTON	TABLET	10	13
68462-333-90	Pramipexole dihydrochloride	90 in 1 BOTTLE	TABLET	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-333-90	EA - Each	68462-333	012779d2-b87e-4ca5-b7f5-e614f782eff1	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 [GLENMARK PHARMACEUTICALS INC., USA]	4
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-333	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12	Current NDC, Legacy NDC, 4 package rows	20240104_44c336d2-01d1-4f13-bad9-549cdc3505ec.zip

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	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	PSN	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
858625	pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	44c336d2-01d1-4f13-bad9-549cdc3505ec	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-333-05	68462033305	500 TABLET in 1 BOTTLE (68462-333-05)	500 tablet	2010-10-08	0000-00-00	No	No	Current
68462-333-11	68462033311	10 BLISTER PACK in 1 CARTON (68462-333-11) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2010-10-08	0000-00-00	No	No	Current
68462-333-90	68462033390	90 TABLET in 1 BOTTLE (68462-333-90)	90 tablet	2010-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Ltd.	2025-12-30	HUMAN PRESCRIPTION DRUG LABEL	13