Home NDC 0597-0285 Mirapex
Product NDC 0597-0285
11-digit product format 005970285
Labeler code 0597
Product ID 0597-0285_52132628-35e3-4594-a642-da7162158112
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pramipexole dihydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA022421
Marketing category NDA
Marketing start 2010-02-22
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 2023-12-31
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 · 46 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 N022421-001 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 N022421-002 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 N022421-003 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 N022421-004 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 N022421-005 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 N022421-006 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 N022421-007 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022421-001 7695734 2028-04-26 Drug product N022421-001 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-002 7695734 2028-04-26 Drug product N022421-002 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-003 7695734 2028-04-26 Drug product N022421-003 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-004 7695734 2028-04-26 Drug product N022421-004 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-005 7695734 2028-04-26 Drug product N022421-005 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-006 7695734 2028-04-26 Drug product 2011-06-30 N022421-006 8679533 2029-09-08 U-219 Drug product 2014-03-25 N022421-007 7695734 2028-04-26 Drug product 2011-06-30 N022421-007 8679533 2029-09-08 U-219 Drug product 2014-03-25
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 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-006 MIRAPEX ER 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-007 MIRAPEX ER 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-006 MIRAPEX ER 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-007 MIRAPEX ER 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-006 MIRAPEX ER 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-007 MIRAPEX ER 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-006 MIRAPEX ER 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022421-007 MIRAPEX ER 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-006 MIRAPEX ER 2.25MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022421-007 MIRAPEX ER 3.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2011-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022421-001 MIRAPEX ER 0.375MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022421-002 MIRAPEX ER 0.75MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022421-003 MIRAPEX ER 1.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022421-004 MIRAPEX ER 3MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022421-005 MIRAPEX ER 4.5MG TABLET, EXTENDED RELEASE / ORAL RLD 2010-02-19 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
Observed Orange Book patent history# Patent history page 1 of 16 · 602 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022421-001 7695734 2028-04-26 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-001 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-002 7695734 2028-04-26 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-002 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-003 7695734 2028-04-26 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-003 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-004 7695734 2028-04-26 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-004 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-005 7695734 2028-04-26 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-005 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-006 7695734 2028-04-26 Drug product 2011-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-006 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-007 7695734 2028-04-26 Drug product 2011-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022421-007 8679533 2029-09-08 U-219 Drug product 2014-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022421-001 7695734 2028-04-26 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-001 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-002 7695734 2028-04-26 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-002 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-003 7695734 2028-04-26 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-003 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-004 7695734 2028-04-26 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-004 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-005 7695734 2028-04-26 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-005 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-006 7695734 2028-04-26 Drug product 2011-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-006 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-007 7695734 2028-04-26 Drug product 2011-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022421-007 8679533 2029-09-08 U-219 Drug product 2014-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022421-001 7695734 2028-04-26 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-001 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-002 7695734 2028-04-26 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-002 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-003 7695734 2028-04-26 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-003 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-004 7695734 2028-04-26 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-004 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-005 7695734 2028-04-26 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-005 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-006 7695734 2028-04-26 Drug product 2011-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022421-006 8679533 2029-09-08 U-219 Drug product 2014-03-25 011fe1cb6892…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0597-0285-17 00597028517 1 BOTTLE, PLASTIC in 1 CARTON (0597-0285-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2010-02-22 0000-00-00 No No Current 0597-0285-30 00597028530 1 BOTTLE, PLASTIC in 1 CARTON (0597-0285-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2010-02-22 0000-00-00 No No Current