FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
70934-596
11-digit product format
709340596
Labeler code
70934
Product ID
70934-596_ab9634bd-422a-2f73-e053-2995a90a802f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA090781
Marketing category
ANDA
Marketing start
2020-02-28
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-596DDiscontinued by firm2026-08-03
excluded packagepackage70934-59670934-596-30DDiscontinued by firm2026-08-03

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-596-302023-02-06C16284748780-1d6a99b39-7a59-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997
70934-596-302022-01-28C16284748780-1d6a99b39-7a59-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-596-307093405963030 TABLET in 1 BOTTLE, PLASTIC (70934-596-30) 30 tablet2020-02-280000-00-00NoNoCurrent