Mirapex

Product NDC: 21695-867
11-digit product format: 216950867
Labeler code: 21695
Product ID: 21695-867_b5504316-3907-444c-b604-ec9a18cdcd6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pramipexole dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020667
Marketing category: NDA
Marketing start: 2004-01-01
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: 2017-12-31
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	21695-867		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-867	21695-867-90	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 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	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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`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	21695-867-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-867-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-867-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-867-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-867-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-867-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-867-90	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-867-90	`110d247fa046…`	`a55b01930146…`

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
N020667-001	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-002	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-003	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-004	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1.25MG	TABLET / ORAL		1997-07-01
N020667-005	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-006	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12
N020667-007	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30

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	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N020667-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020667-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020667-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020667-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-007	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020667-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020667-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-005	AB	1	`8869cabd3fbd…`

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
21695-867-90	2019-09-24	C162847	48780-1	934fe258-488d-48b1-e053-8cdaa90a720a	Mirapex ® (pramipexole dihydrochloride) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-867-90	Mirapex	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-867-90	EA - Each	21695-867	aaa971d3-7afb-40cc-8f71-22cedeb6a7cb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
pramipexole dihydrochloride	ACTIVE INGREDIENT	3D867NP06J	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
pramipexole	ACTIVE MOIETY	83619PEU5T	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-867	MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_b5504316-3907-444c-b604-ec9a18cdcd6d.zip

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
859046	Mirapex 0.5 MG Oral Tablet	PSN	b5504316-3907-444c-b604-ec9a18cdcd6d	1
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	b5504316-3907-444c-b604-ec9a18cdcd6d	1
859046	pramipexole dihydrochloride 0.5 MG Oral Tablet [Mirapex]	SBD	b5504316-3907-444c-b604-ec9a18cdcd6d	1
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	b5504316-3907-444c-b604-ec9a18cdcd6d	1
859046	Mirapex 0.5 MG Oral Tablet	SY	b5504316-3907-444c-b604-ec9a18cdcd6d	1
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	b5504316-3907-444c-b604-ec9a18cdcd6d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-867-90	21695086790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mirapex ® (pramipexole dihydrochloride) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg Tablets	Rebel Distributors Corp	2010-12-29	HUMAN PRESCRIPTION DRUG LABEL	1