Home NDC 50090-2190 Pramipexole dihydrochloride
Product NDC 50090-2190
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# 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-2190-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-2190-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-2190-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-2190-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-2190-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-2190-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2190-0 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2190-0 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2190-0 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2190-0 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2190-0 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2190-0 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-2190-0 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-2190-0 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-2190-0 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 252 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 2026-08-18 06:07:40 2026-07 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
FDA-Initiated Inactive NDC Indexing# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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