Home NDC 0781-5249 Pramipexole Dihydrochloride
Product NDC 0781-5249
11-digit product format 007815249
Labeler code 0781
Product ID 0781-5249_57121d70-d083-4862-b4e5-c69e12067089
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pramipexole Dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA090190
Marketing category ANDA
Marketing start 2010-07-06
Marketing end 0000-00-00
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength 0 mg/1
Pharmacologic classes Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 75 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08
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 7 · 258 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 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090190-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090190-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090190-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090190-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090190-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-07-06 b8a1b40f171c…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0781-5249-13 2021-04-09 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-31 2021-04-09 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-60 2021-04-09 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-92 2021-04-09 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-13 2020-01-31 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-31 2020-01-31 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-60 2020-01-31 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997 0781-5249-92 2020-01-31 These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Socrata Ingredients#