Home NDC 0597-0190 Mirapex
Product NDC 0597-0190
11-digit product format 005970190
Labeler code 0597
Product ID 0597-0190_b530bc3b-69a8-a6a3-c79a-93714d39a718
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 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 2022-12-31
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MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-002 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-003 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-004 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.25MG TABLET / ORAL 1997-07-01 N020667-005 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-07-01 N020667-006 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-02-12 N020667-007 MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG **Federal Register determination that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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded pramipexole dihydrochloride ACTIVE INGREDIENT 3D867NP06J MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 18 pramipexole ACTIVE MOIETY 83619PEU5T MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 18 pramipexole dihydrochloride ACTIVE INGREDIENT 3D867NP06J MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 pramipexole ACTIVE MOIETY 83619PEU5T MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 povidone INACTIVE INGREDIENT FZ989GH94E MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0190-90 00597019090 90 TABLET in 1 BOTTLE (0597-0190-90) 90 tablet 2004-01-01 0000-00-00 No No Current