Pramipexole Dihydrochloride

Product NDC
71335-0584
11-digit product format
713350584
Labeler code
71335
Product ID
71335-0584_b042def2-13f3-48c8-9a05-5b56ab536372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090865
Marketing category
ANDA
Marketing start
2010-10-08
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859044Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
350a3f84-0f98-405f-bdae-6abbc47d48a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a67b8488-0225-64b1-be81-5cbe60d285a5Product name920221116
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3863aae0-7028-3427-389e-3f6c8692e587Product name320190117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0584-1Pramipexole Dihydrochloride90 in 1 BOTTLETABLET9010
71335-0584-2Pramipexole Dihydrochloride30 in 1 BOTTLETABLET3010
71335-0584-3Pramipexole Dihydrochloride60 in 1 BOTTLETABLET6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0584-2EA - Each71335-058426aee459-e1d4-421b-b13c-1a778df6d7b312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0584PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 3 package rows20240830_350a3f84-0f98-405f-bdae-6abbc47d48a4.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
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
ndc (product): 71335-0584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN350a3f84-0f98-405f-bdae-6abbc47d48a410
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD350a3f84-0f98-405f-bdae-6abbc47d48a410
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY350a3f84-0f98-405f-bdae-6abbc47d48a410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0584-17133505840190 TABLET in 1 BOTTLE (71335-0584-1) 90 tablet2018-07-020000-00-00NoNoCurrent
71335-0584-27133505840230 TABLET in 1 BOTTLE (71335-0584-2) 30 tablet2018-04-240000-00-00NoNoCurrent
71335-0584-37133505840360 TABLET in 1 BOTTLE (71335-0584-3) 60 tablet2022-05-020000-00-00NoNoCurrent