Pramipexole Dihydrochloride

Product NDC
60429-088
11-digit product format
604290088
Labeler code
60429
Product ID
60429-088_494fcbc6-e427-a591-e063-6394a90ae5df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203855
Marketing category
ANDA
Marketing start
2014-10-28
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.75 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A203855-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-28
A203855-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-28
A203855-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-28
A203855-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-28
A203855-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-28
A203855-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203855-001AB
A203855-002AB
A203855-003AB
A203855-004AB
A203855-005AB
A203855-006AB

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 UTC2026-02A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2014-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2014-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2014-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2014-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2014-10-282680178bc6a6…

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 UTC2026-02A203855-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203855-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203855-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203855-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203855-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203855-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203855-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203855-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203855-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole Dihydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3D867NP06JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858625Internal RxNorm lookup
859033Internal RxNorm lookup
859040Internal RxNorm lookup
859044Internal RxNorm lookup
859048Internal RxNorm lookup
859052Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ac759f-59fb-49e4-a772-4114facdaea3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-088-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-088-90EA - Each60429-088bbb89529-65c5-45ec-96e4-231f28db653012025-06-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-088PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]14Current NDC, 1 package rows20250509_f8ac759f-59fb-49e4-a772-4114facdaea3.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGolden State Medical Supply, Inc.f8ac759f-59fb-49e4-a772-4114facdaea32026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203855
application number: ANDA203855
ndc (product): 60429-088
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEScieGen Pharmaceuticals Inc395fee34-43dc-4840-a6b8-70d5736f9c8b2025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203855
application number: ANDA203855
PRAMIPEXOLEPRAMIPEXOLECamber Pharmaceuticals, Inc.a7405a56-de1c-4875-b57f-210c991474ba2016-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203855
application number: ANDA203855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSNf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCDf8ac759f-59fb-49e4-a772-4114facdaea315
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSYf8ac759f-59fb-49e4-a772-4114facdaea315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60429-088-906042900889090 TABLET in 1 BOTTLE (60429-088-90) 90 tablet2025-05-02NoNoCurrent