Pramipexole Dihydrochloride

Product NDC
60687-570
11-digit product format
606870570
Labeler code
60687
Product ID
60687-570_4c252238-7629-b19d-e063-6294a90a4c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090865
Marketing category
ANDA
Marketing start
2020-08-18
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
A090865-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08
A090865-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-08
A090865-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08
A090865-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-08
A090865-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08
A090865-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090865-001AB
A090865-002AB
A090865-003AB
A090865-004AB
A090865-005AB
A090865-006AB

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 UTC2026-02A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-005PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-006PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-004PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / 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 UTC2026-02A090865-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090865-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090865-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090865-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090865-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090865-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090865-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090865-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090865-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859040Internal RxNorm lookup
859044Internal 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
f4d97c2e-f447-4cfe-b9d4-852323f0cfb5Available 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
60687-570-01Pramipexole Dihydrochloride100 in 1 BOX, UNIT-DOSETABLET1005
60687-570-11Pramipexole Dihydrochloride1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-570-01EA - Each60687-570234c1e05-4aa0-40df-af3e-7b76e5484a2212020-08-06
60687-570-11EA - Each60687-570010b6ad7-07ff-41c3-b71e-d1ba3f11170612020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-570PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20241004_f4d97c2e-f447-4cfe-b9d4-852323f0cfb5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack46f88017-7b0e-437e-90b1-37bdf9013e722026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions3db0613d-524b-4b33-9a07-602f84d6c3042026-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackbd0f7ae1-11ef-4fab-894f-c4c59f75aa992026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackdd4b4e2a-97b5-417d-bb90-bec692dc359b2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDETorrent Pharmaceuticals Limited60167d7c-469f-455a-a113-561841af5e592026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAmerican Health Packagingf4d97c2e-f447-4cfe-b9d4-852323f0cfb52026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
ndc (product): 60687-570
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEMajor Pharmaceuticals978c0e89-35f0-44a2-9302-8bed7e5d60e02026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack794fdab8-1c15-4469-963e-4f9e3495536f2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack350a3f84-0f98-405f-bdae-6abbc47d48a42024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090865
application number: ANDA090865

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG Oral TabletPSNf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG Oral TabletSCDf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSYf4d97c2e-f447-4cfe-b9d4-852323f0cfb55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-570-0160687057001100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-570-01) / 1 TABLET in 1 BLISTER PACK (60687-570-11) 100 blister pack2020-08-180000-00-00NoNoCurrent
60687-570-11606870570111 in 1 BLISTER PACKHistorical