Home NDC 50090-2190-0 Pramipexole dihydrochloride
Product NDC 50090-2190
Requested package NDC 50090-2190-0
11-digit product format 500902190
Labeler code 50090
Product ID 50090-2190_dcdcf439-fbb9-4bd0-a5e5-f2ee87add044
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pramipexole dihydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA090781
Marketing category ANDA
Marketing start 2010-10-08
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 No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 9 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 · 246 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 2026-02-19 14:30 UTC 2026-02 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-2190-0 50090219000 90 TABLET in 1 BOTTLE (50090-2190-0) 90 tablet 2015-10-26 0000-00-00 No No Current