Pramipexole Dihydrochloride

Product NDC
60429-086
Requested package NDC
60429-086-90
11-digit product format
604290086
Labeler code
60429
Product ID
60429-086_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
.25 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…

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 · 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 (package): 60429-086-90
ndc (product): 60429-086
ndc11 (package): 60429008690
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.25 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
60429-086-90Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-086-90EA - Each60429-08686abb97d-c8bc-4723-b116-5a2543ee284a12015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-086PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]14Current NDC, Legacy NDC, 1 package rows20250509_f8ac759f-59fb-49e4-a772-4114facdaea3.zip

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 startMarketing endSampleExclude flagStatus
60429-086-906042900869090 TABLET in 1 BOTTLE (60429-086-90) 90 tablet2025-04-070000-00-00NoNoCurrent