Pramipexole Dihydrochloride

Product NDC
63629-5034
Requested package NDC
63629-5034-2
11-digit product format
636295034
Labeler code
63629
Product ID
63629-5034_a41fc541-969c-4928-b43a-fc129fefb900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078920
Marketing category
ANDA
Marketing start
2010-07-10
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-503463629-5034-2DDiscontinued by firm2026-09-14

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078920-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06
A078920-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06
A078920-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06
A078920-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06
A078920-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06
A078920-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078920-001AB
A078920-002AB
A078920-003AB
A078920-004AB
A078920-005AB
A078920-006AB

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 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078920-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A078920-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078920-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078920-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-004AB1b8a1b40f171c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-5034-12022-02-16These 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
63629-5034-22022-02-16These 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
63629-5034-32022-02-16These 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
63629-5034-12019-11-27These 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
63629-5034-22019-11-27These 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
63629-5034-32019-11-27These 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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5034-26362950340230 TABLET in 1 BOTTLE (63629-5034-2) 30 tablet2013-07-150000-00-00NoNoCurrent