Pramipexole Dihydrochloride

Product NDC: 42543-708
11-digit product format: 425430708
Labeler code: 42543
Product ID: 42543-708_95e8a82c-d86b-4179-9412-981b550ba132
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Vensun Pharmaceuticals, Inc.
Application: ANDA203855
Marketing category: ANDA
Marketing start: 2014-10-29
Marketing end: 0000-00-00
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42543-708		I	Inactivated by FDA	2026-08-17
excluded package	package	42543-708	42543-708-05	I	Inactivated by FDA	2026-08-17
excluded package	package	42543-708	42543-708-10	I	Inactivated by FDA	2026-08-17
excluded package	package	42543-708	42543-708-90	I	Inactivated by FDA	2026-08-17

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42543-708-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42543-708-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42543-708-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42543-708-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42543-708-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42543-708-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42543-708-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42543-708-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42543-708-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42543-708-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42543-708-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42543-708-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42543-708-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42543-708-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42543-708-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42543-708-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42543-708-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42543-708-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42543-708-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42543-708-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42543-708-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42543-708-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42543-708-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42543-708-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42543-708-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42543-708-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42543-708-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42543-708-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42543-708-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42543-708-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42543-708-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42543-708-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42543-708-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42543-708-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42543-708-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42543-708-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42543-708-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42543-708-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42543-708-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42543-708-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42543-708-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42543-708-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42543-708-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42543-708-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42543-708-05	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28
A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28
A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28
A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28
A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28
A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203855-001	AB
A203855-002	AB
A203855-003	AB
A203855-004	AB
A203855-005	AB
A203855-006	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 · 252 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	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 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	A203855-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203855-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203855-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203855-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203855-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203855-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203855-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203855-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203855-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203855-004	AB	1	`03ed91905a0d…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42543-708-05	2020-01-31	C162847	48780-1	9d75b9cf-dac0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
42543-708-10	2020-01-31	C162847	48780-1	9d75b9cf-dac0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
42543-708-90	2020-01-31	C162847	48780-1	9d75b9cf-dac0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42543-708-05	Pramipexole Dihydrochloride	500 in 1 BOTTLE	TABLET	500	7
42543-708-10	Pramipexole Dihydrochloride	1000 in 1 BOTTLE	TABLET	1000	7
42543-708-90	Pramipexole Dihydrochloride	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-708-90	EA - Each	42543-708	cff2342c-e38e-4ff8-843c-3a06561c4733	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-708	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	7	Legacy NDC, 3 package rows	20180809_2cc30954-ba71-4313-bd69-b718da254b5a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	f8ac759f-59fb-49e4-a772-4114facdaea3	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203855 application number: ANDA203855
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	ScieGen Pharmaceuticals Inc	395fee34-43dc-4840-a6b8-70d5736f9c8b	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203855 application number: ANDA203855
PRAMIPEXOLE	PRAMIPEXOLE	Camber Pharmaceuticals, Inc.	a7405a56-de1c-4875-b57f-210c991474ba	2016-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203855 application number: ANDA203855

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	2cc30954-ba71-4313-bd69-b718da254b5a	7
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	2cc30954-ba71-4313-bd69-b718da254b5a	7
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	2cc30954-ba71-4313-bd69-b718da254b5a	7
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	PSN	2cc30954-ba71-4313-bd69-b718da254b5a	7
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	2cc30954-ba71-4313-bd69-b718da254b5a	7
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	2cc30954-ba71-4313-bd69-b718da254b5a	7
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	2cc30954-ba71-4313-bd69-b718da254b5a	7
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7
858625	pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	2cc30954-ba71-4313-bd69-b718da254b5a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42543-708-05	42543070805	500 in 1 BOTTLE	Historical
42543-708-10	42543070810	1000 in 1 BOTTLE	Historical
42543-708-90	42543070890	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Vensun Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2018-08-08	HUMAN PRESCRIPTION DRUG LABEL	7