FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
68462-332
11-digit product format
684620332
Labeler code
68462
Product ID
68462-332_75644134-fcad-4dde-8a22-453d18472002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090781
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
A090781-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08
A090781-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08
A090781-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08
A090781-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08
A090781-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08
A090781-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090781-001AB
A090781-002AB
A090781-003AB
A090781-004AB
A090781-005AB
A090781-006AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090781-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-10-08a50c72e98297…
2026-08-01 22:54:322026-06A090781-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALABRS2010-10-08a50c72e98297…
2026-08-01 22:54:322026-06A090781-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-10-08a50c72e98297…
2026-08-01 22:54:322026-06A090781-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-10-08a50c72e98297…
2026-08-01 22:54:322026-06A090781-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-10-08a50c72e98297…
2026-08-01 22:54:322026-06A090781-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2015-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090781-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090781-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090781-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A090781-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A090781-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A090781-006AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA44c336d2-01d1-4f13-bad9-549cdc3505ec2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090781
application number: ANDA090781
ndc (product): 68462-332
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5e6f2187-a5cc-481e-b0a1-d38d3f92e8222024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090781
application number: ANDA090781

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 · 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
44c336d2-01d1-4f13-bad9-549cdc3505ecAvailable 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
68462-332-05Pramipexole dihydrochloride500 in 1 BOTTLETABLET50013
68462-332-11Pramipexole dihydrochloride10 in 1 BLISTER PACKTABLET1013
68462-332-11Pramipexole dihydrochloride10 in 1 CARTONTABLET1013
68462-332-90Pramipexole dihydrochloride90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-332-90EA - Each68462-332981f6d7b-3e8b-49fa-adcb-463dfb585a5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-332PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 4 package rows20240104_44c336d2-01d1-4f13-bad9-549cdc3505ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859033pramipexole dihydrochloride 0.125 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG Oral TabletPSN44c336d2-01d1-4f13-bad9-549cdc3505ec13
859033pramipexole dihydrochloride 0.125 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG Oral TabletSCD44c336d2-01d1-4f13-bad9-549cdc3505ec13
859033pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
858625pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859052pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859048pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral TabletSY44c336d2-01d1-4f13-bad9-549cdc3505ec13
859040pramipexole dihydrochloride 0.25 MG Oral TabletPSN5e6f2187-a5cc-481e-b0a1-d38d3f92e8221
859044pramipexole dihydrochloride 0.5 MG Oral TabletPSN5e6f2187-a5cc-481e-b0a1-d38d3f92e8221
859040pramipexole dihydrochloride 0.25 MG Oral TabletSCD5e6f2187-a5cc-481e-b0a1-d38d3f92e8221
859044pramipexole dihydrochloride 0.5 MG Oral TabletSCD5e6f2187-a5cc-481e-b0a1-d38d3f92e8221
859040pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral TabletSY5e6f2187-a5cc-481e-b0a1-d38d3f92e8221
859044pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral TabletSY5e6f2187-a5cc-481e-b0a1-d38d3f92e8221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-332-0568462033205500 TABLET in 1 BOTTLE (68462-332-05) 500 tablet2010-10-080000-00-00NoNoCurrent
68462-332-116846203321110 BLISTER PACK in 1 CARTON (68462-332-11) / 10 TABLET in 1 BLISTER PACK10 blister pack2010-10-080000-00-00NoNoCurrent
68462-332-906846203329090 TABLET in 1 BOTTLE (68462-332-90) 90 tablet2010-10-080000-00-00NoNoCurrent