Home NDC 0597-0191 Mirapex
Product NDC 0597-0191
11-digit product format 005970191
Labeler code 0597
Product ID 0597-0191_9db9830c-e088-f669-99ad-611ca38ab2ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pramipexole dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA020667
Marketing category NDA
Marketing start 2004-01-01
Marketing end 2020-04-30
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes 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MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-002 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-003 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-004 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.25MG TABLET / ORAL 1997-07-01 N020667-005 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-006 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-02-12 N020667-007 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG **Federal Register determination that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 · 301 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020667-004 MIRAPEX 1.25MG TABLET / ORAL 1997-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#