Pramipexole Dihydrochloride

Product NDC: 46708-577
11-digit product format: 467080577
Labeler code: 46708
Product ID: 46708-577_c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA204518
Marketing category: ANDA
Marketing start: 2019-01-03
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 2.25 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 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A204518-001	AB
A204518-002	AB
A204518-003	AB
A204518-004	AB
A204518-005	AB
A204518-006	AB
A204518-007	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 8 · 294 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
2026-08-18 06:07:40	2026-07	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 245 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204518-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204518-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204518-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-005	AB	1	`b8a1b40f171c…`

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	2.25 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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901534	Internal RxNorm lookup
901541	Internal RxNorm lookup
901546	Internal RxNorm lookup
901550	Internal RxNorm lookup
901555	Internal RxNorm lookup
1114479	Internal RxNorm lookup
1114485	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
b6935240-ee81-49ef-adad-fb900d7f5127	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
46708-577-30	Pramipexole Dihydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-577	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 1 package rows	20230202_b6935240-ee81-49ef-adad-fb900d7f5127.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 · 2 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.	e18b67b6-a085-43e5-bb2b-fe74fa00cb65	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204518 application number: ANDA204518
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	b6935240-ee81-49ef-adad-fb900d7f5127	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204518 application number: ANDA204518 ndc (product): 46708-577

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
901541	pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
901546	pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
901550	pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114479	pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
901555	pramipexole dihydrochloride 3 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114485	pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
901534	pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral Tablet	PSN	b6935240-ee81-49ef-adad-fb900d7f5127	2
901541	24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
901546	24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
901550	24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114479	24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
901555	24 HR pramipexole dihydrochloride 3 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114485	24 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
901534	24 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral Tablet	SCD	b6935240-ee81-49ef-adad-fb900d7f5127	2
901541	pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
901546	pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
901550	pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114479	pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
901555	pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
1114485	pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
901534	pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2
901546	pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral Tablet	SY	b6935240-ee81-49ef-adad-fb900d7f5127	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-577-30	46708057730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-577-30)	2019-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	2023-01-27	Human Prescription Drug Label	2