Pramipexole dihydrochloride

Product NDC
50090-2217
Requested package NDC
50090-2217-0
11-digit product format
500902217
Labeler code
50090
Product ID
50090-2217_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
1 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-221750090-2217-0DDiscontinued by firm2026-08-03

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-221750090-2217-0IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090781-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08
A090781-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08
A090781-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08
A090781-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08
A090781-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08
A090781-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A090781-001AB
A090781-002AB
A090781-003AB
A090781-004AB
A090781-005AB
A090781-006AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090781-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090781-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090781-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090781-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090781-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090781-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090781-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090781-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090781-004AB12680178bc6a6…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA44c336d2-01d1-4f13-bad9-549cdc3505ec2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090781
application number: ANDA090781
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5e6f2187-a5cc-481e-b0a1-d38d3f92e8222024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090781
application number: ANDA090781

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2217-0EA - Each50090-2217403455dc-9dd0-479b-88ea-c948b799c51e12021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2217-05009022170030 TABLET in 1 BOTTLE (50090-2217-0) 30 tablet2015-11-030000-00-00NoNoCurrent