Application 022421

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.375MG	Yes	Yes
002	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.75MG	Yes	No
003	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	Yes	No
004	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	Yes	No
005	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	Yes	No
006	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.25MG	Yes	No
007	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3.75MG	Yes	No

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	RLD / RS	Approval date
N022421-001	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-002	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-003	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-004	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-005	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-006	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17
N022421-007	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022421-001	7695734	2028-04-26		Drug product
N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-002	7695734	2028-04-26		Drug product
N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-003	7695734	2028-04-26		Drug product
N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-004	7695734	2028-04-26		Drug product
N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-005	7695734	2028-04-26		Drug product
N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-006	7695734	2028-04-26		Drug product	2011-06-30
N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-007	7695734	2028-04-26		Drug product	2011-06-30
N022421-007	8679533	2029-09-08	U-219	Drug product	2014-03-25

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-006	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022421-007	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-006	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022421-007	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-006	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022421-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022421-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-006	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022421-007	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022421-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022421-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022421-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022421-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022421-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022421-005	AB	1	`5d02ea3f76ae…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022421-001	7695734	2028-04-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-002	7695734	2028-04-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-003	7695734	2028-04-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-004	7695734	2028-04-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-005	7695734	2028-04-26		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-006	7695734	2028-04-26		Drug product	2011-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-007	7695734	2028-04-26		Drug product	2011-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022421-007	8679533	2029-09-08	U-219	Drug product	2014-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022421-001	7695734	2028-04-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-002	7695734	2028-04-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-003	7695734	2028-04-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-004	7695734	2028-04-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-005	7695734	2028-04-26		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-006	7695734	2028-04-26		Drug product	2011-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-007	7695734	2028-04-26		Drug product	2011-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022421-007	8679533	2029-09-08	U-219	Drug product	2014-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-001	7695734	2028-04-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-002	7695734	2028-04-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-003	7695734	2028-04-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-004	7695734	2028-04-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-005	7695734	2028-04-26		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-006	7695734	2028-04-26		Drug product	2011-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25	`31067a03dcf5…`

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 2 · 36 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	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	46f88017-7b0e-437e-90b1-37bdf9013e72	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	3db0613d-524b-4b33-9a07-602f84d6c304	2026-04-26	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	bd0f7ae1-11ef-4fab-894f-c4c59f75aa99	2026-04-03	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	dd4b4e2a-97b5-417d-bb90-bec692dc359b	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Torrent Pharmaceuticals Limited	60167d7c-469f-455a-a113-561841af5e59	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	American Health Packaging	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	f8ac759f-59fb-49e4-a772-4114facdaea3	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Major Pharmaceuticals	978c0e89-35f0-44a2-9302-8bed7e5d60e0	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	44c336d2-01d1-4f13-bad9-549cdc3505ec	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	ScieGen Pharmaceuticals Inc	395fee34-43dc-4840-a6b8-70d5736f9c8b	2025-12-24	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Rising Pharma Holdings, Inc.	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	794fdab8-1c15-4469-963e-4f9e3495536f	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	b978aa75-c62d-444b-9ec6-6c0d21a66688	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78753	SUPPL	2024-07-02
78776	SUPPL	2024-06-12
68087	SUPPL	2021-07-14
68078	SUPPL	2021-07-14
64193	SUPPL	2020-08-04
61741	SUPPL	2020-01-30
54194	SUPPL	2018-05-15
54141	SUPPL	2018-05-11
38690	SUPPL	2016-08-02
7368	SUPPL	2016-08-01
17569	SUPPL	2016-01-15
7367	SUPPL	2016-01-15
38689	SUPPL	2015-04-02
7366	SUPPL	2015-04-01
17567	SUPPL	2014-05-12
29708	SUPPL	2014-05-09
38688	SUPPL	2013-03-05
29709	SUPPL	2013-03-04
44184	ORIG	2012-09-19
17568	SUPPL	2012-09-06
7365	SUPPL	2012-09-05
42519	ORIG	2010-08-20
24303	ORIG	2010-08-20
38687	SUPPL	2010-07-22
7364	SUPPL	2010-07-15
7363	ORIG	2010-02-26
38686	ORIG	2010-02-25