Pramipexole Dihydrochloride

Product NDC: 65862-608
11-digit product format: 658620608
Labeler code: 65862
Product ID: 65862-608_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202633
Marketing category: ANDA
Marketing start: 2012-10-26
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

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
unfinished product	product	65862-608		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-608	65862-608-35	UNFINISHED	Active or certified unfinished drug listing		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 · 42 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-608-35	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-608-35	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-608-35	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-608-35	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-608-35	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-608-35	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-608-35	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-608-35	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-608-35	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-608-35	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-608-35	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-608-35	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-608-35	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-608-35	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-608-35	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-608-35	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-608-35	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-608-35	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-608-35	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-608-35	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-608-35	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26
A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26
A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26
A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26
A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26
A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202633-001	AB
A202633-002	AB
A202633-003	AB
A202633-004	AB
A202633-005	AB
A202633-006	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	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-005	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-006	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2012-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2012-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-004	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2012-10-26	`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	A202633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202633-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202633-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202633-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202633-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202633-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202633-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202633-004	AB	1	`2680178bc6a6…`

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858625	Internal RxNorm lookup
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
3f90971a-e005-4dd3-bb93-b09125ada3c8	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-608-10	Pramipexole Dihydrochloride	10 in 1 BLISTER PACK	TABLET	10	15
65862-608-78	Pramipexole Dihydrochloride	10 in 1 CARTON	TABLET	10	15
65862-608-90	Pramipexole Dihydrochloride	90 in 1 BOTTLE	TABLET	90	15
65862-608-99	Pramipexole Dihydrochloride	1000 in 1 BOTTLE	TABLET	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-608-90	EA - Each	65862-608	7ba3ba48-b295-491e-8f40-3c1e25f4b401	1	2013-09-04
65862-608-99	EA - Each	65862-608	9f62630b-049e-4a2e-9db6-4b6804b26c81	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-608	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	14	Current NDC, Legacy NDC, 4 package rows	20240218_3f90971a-e005-4dd3-bb93-b09125ada3c8.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	468830df-941c-4363-b432-94de9b7fd2ac	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Rising Pharma Holdings, Inc.	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Aurobindo Pharma Limited	3f90971a-e005-4dd3-bb93-b09125ada3c8	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633 ndc (product): 65862-608
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	29b639e3-25a5-4c2f-b4ea-a119db79fe0c	2024-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	7cd6a546-d516-427c-af79-555390ccd35b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202633 application number: ANDA202633

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	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	PSN	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
858625	pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	3f90971a-e005-4dd3-bb93-b09125ada3c8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-608-10	65862060810	10 in 1 BLISTER PACK						Historical
65862-608-35	65862060835	3500 TABLET in 1 BAG (65862-608-35)	3500 tablet	26-OCT-12				Current
65862-608-78	65862060878	10 BLISTER PACK in 1 CARTON (65862-608-78) / 10 TABLET in 1 BLISTER PACK (65862-608-10)	10 blister pack	2012-10-26	0000-00-00	No	No	Current
65862-608-90	65862060890	90 TABLET in 1 BOTTLE (65862-608-90)	90 tablet	2012-10-26	0000-00-00	No	No	Current
65862-608-99	65862060899	1000 TABLET in 1 BOTTLE (65862-608-99)	1000 tablet	2012-10-26	0000-00-00	No	No	Current