Pramipexole dihydrochloride

Product NDC: 33342-034
Requested package NDC: 33342-034-12
11-digit product format: 333420034
Labeler code: 33342
Product ID: 33342-034_721c81fc-fd21-4d86-ab96-9a329b8e015b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202164
Marketing category: ANDA
Marketing start: 2012-09-21
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

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20
A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20
A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20
A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20
A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20

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	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`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	A202164-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A202164-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202164-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202164-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-005	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
b8c94917-73a1-44c2-8fd8-07f45054176b	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	SPL version
33342-034-06	Pramipexole dihydrochloride	1 in 1 BLISTER PACK	TABLET	1	10
33342-034-06	Pramipexole dihydrochloride	30 in 1 CARTON	TABLET	30	10
33342-034-10	Pramipexole dihydrochloride	90 in 1 BOTTLE	TABLET	90	10
33342-034-12	Pramipexole dihydrochloride	1 in 1 BLISTER PACK	TABLET	1	10
33342-034-12	Pramipexole dihydrochloride	100 in 1 CARTON	TABLET	100	10
33342-034-15	Pramipexole dihydrochloride	500 in 1 BOTTLE	TABLET	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-034-10	EA - Each	33342-034	eabd0c08-69ed-4d85-bae5-4645a537d1fc	1	2013-08-02
33342-034-15	EA - Each	33342-034	f31dd290-0fca-400b-8456-c4d0395b0a14	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202164 application number: ANDA202164 ndc (package): 33342-034-12 ndc (product): 33342-034 ndc11 (package): 33342003412

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	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	b8c94917-73a1-44c2-8fd8-07f45054176b	10
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	5d7c2fc2-279c-4723-b4ec-640220f2740e	3
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	5d7c2fc2-279c-4723-b4ec-640220f2740e	3
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	5d7c2fc2-279c-4723-b4ec-640220f2740e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
33342-034-12	33342003412	100 BLISTER PACK in 1 CARTON (33342-034-12) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2012-09-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	2025-10-15	Human Prescription Drug Label	10
Pramipexole dihydrochloride	A-S Medication Solutions	2020-01-18	Human Prescription Drug Label	3