FDA.reportPublic FDA data

Pramipexole dihydrochloride

Product NDC
50742-331
11-digit product format
507420331
Labeler code
50742
Product ID
50742-331_74c3457e-079c-4b2b-bae4-3f148540a27a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA213444
Marketing category
ANDA
Marketing start
2022-03-10
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
.375 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213444-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03
A213444-007PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A213444-001AB
A213444-002AB
A213444-003AB
A213444-004AB
A213444-005AB
A213444-006AB
A213444-007AB

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 6 · 224 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-006PRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-007PRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-006PRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-007PRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-006PRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-007PRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-006PRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-007PRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-006PRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-007PRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-001PRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-002PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-003PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-004PRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-005PRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALAB2022-02-0303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 224 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213444-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213444-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213444-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213444-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213444-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213444-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213444-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213444-005AB103ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Pramipexole dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.375 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
901534Internal RxNorm lookup
901541Internal RxNorm lookup
901546Internal RxNorm lookup
901550Internal RxNorm lookup
901555Internal RxNorm lookup
1114479Internal RxNorm lookup
1114485Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d2b1d2c-ae22-424a-bad7-ce24a817b042Available 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
50742-331-30Pramipexole dihydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-331-30EA - Each50742-331f6a3a1cc-212f-4934-bc1b-ed9bc363a18012022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-331PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20250508_1d2b1d2c-ae22-424a-bad7-ce24a817b042.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEIngenus Pharmaceuticals, LLC1d2b1d2c-ae22-424a-bad7-ce24a817b0422025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213444
application number: ANDA213444
ndc (product): 50742-331

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901541pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901550pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114479pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901555pramipexole dihydrochloride 3 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114485pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901534pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral TabletPSN1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90154124 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90154624 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90155024 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
111447924 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90155524 HR pramipexole dihydrochloride 3 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
111448524 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
90153424 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral TabletSCD1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901541pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901550pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114479pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901555pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
1114485pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901534pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422
901546pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral TabletSY1d2b1d2c-ae22-424a-bad7-ce24a817b0422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-331-305074203313030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-331-30) 2022-03-100000-00-00NoNoCurrent