Pramipexole Dihydrochloride

Product NDC: 68151-3645
11-digit product format: 681513645
Labeler code: 68151
Product ID: 68151-3645_a8261a2f-3381-4684-b33d-f84fec00bf26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA090865
Marketing category: ANDA
Marketing start: 2010-10-08
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: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-3645		I	Inactivated by FDA		2026-08-03
excluded package	package	68151-3645	68151-3645-9	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-3645-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-3645-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-3645-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-3645-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-3645-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-3645-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-3645-9	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-3645-9	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-3645-9	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-3645-9	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-3645-9	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-3645-9	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-3645-9	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-3645-9	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-3645-9	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-3645-9	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-3645-9	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-3645-9	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-3645-9	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-3645-9	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-3645-9	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-3645-9	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date
A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08
A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08
A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08
A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08
A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08
A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090865-001	AB
A090865-002	AB
A090865-003	AB
A090865-004	AB
A090865-005	AB
A090865-006	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	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	A090865-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090865-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090865-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090865-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090865-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090865-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090865-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090865-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090865-004	AB	1	`2680178bc6a6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-3645-9	2020-01-31	C162847	48780-1	9d75b9d0-a531-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	Strength	SPL version
68151-3645-9	Pramipexole Dihydrochloride	1 in 1 PACKAGE	TABLET	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-3645	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20160806_cf89d9ae-decf-4078-8c97-59a6f199ad24.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 · 9 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	46f88017-7b0e-437e-90b1-37bdf9013e72	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	3db0613d-524b-4b33-9a07-602f84d6c304	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	bd0f7ae1-11ef-4fab-894f-c4c59f75aa99	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	dd4b4e2a-97b5-417d-bb90-bec692dc359b	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Torrent Pharmaceuticals Limited	60167d7c-469f-455a-a113-561841af5e59	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	American Health Packaging	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Major Pharmaceuticals	978c0e89-35f0-44a2-9302-8bed7e5d60e0	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	794fdab8-1c15-4469-963e-4f9e3495536f	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	350a3f84-0f98-405f-bdae-6abbc47d48a4	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090865 application number: ANDA090865

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
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	cf89d9ae-decf-4078-8c97-59a6f199ad24	4
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	cf89d9ae-decf-4078-8c97-59a6f199ad24	4
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	cf89d9ae-decf-4078-8c97-59a6f199ad24	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-3645-9	68151364509	1 in 1 PACKAGE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Carilion Materials Management	2016-08-06	HUMAN PRESCRIPTION DRUG LABEL	4