Home NDC 0597-0115 Mirapex
Product NDC 0597-0115
11-digit product format 005970115
Labeler code 0597
Product ID 0597-0115_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 3 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 · 22 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 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 0597-0115-30 367a005e9d99…383a685ebd0f…
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 0597-0115-30 00597011530 1 BOTTLE, PLASTIC in 1 CARTON (0597-0115-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2010-02-22 0000-00-00 No No Current