Pramipexole Dihydrochloride

Product NDC
68382-198
Requested package NDC
68382-198-05
11-digit product format
683820198
Labeler code
68382
Product ID
68382-198_8906b45d-eaeb-4e7f-9aa2-dffa89109a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078920
Marketing category
ANDA
Marketing start
2010-07-10
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-19868382-198-05DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-19868382-198-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-19868382-198-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078920-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06
A078920-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06
A078920-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06
A078920-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06
A078920-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06
A078920-006PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078920-001AB
A078920-002AB
A078920-003AB
A078920-004AB
A078920-005AB
A078920-006AB

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 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-0684e616aacf4f…
2026-09-14 22:38:342026-08A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2010-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-006PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2022-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-001PRAMIPEXOLE DIHYDROCHLORIDE0.125MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-002PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-003PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2010-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2010-07-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078920-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A078920-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A078920-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078920-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078920-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078920-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078920-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078920-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078920-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078920-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078920-004AB1b8a1b40f171c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-198-10EA - Each68382-1985cb83e64-6460-4a18-96d1-0da75907449c12012-07-24
68382-198-16EA - Each68382-1988906c62a-3d22-4966-81d7-9910293d77e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
PRAMIPEXOLE DIHYDROCHLORIDEACTIVE INGREDIENT3D867NP06JPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
PRAMIPEXOLEACTIVE MOIETY83619PEU5TPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
MANNITOLINACTIVE INGREDIENT3OWL53L36APRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRAMIPEXOLE DIHYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-198-0568382019805500 TABLET in 1 BOTTLE (68382-198-05) 500 tablet2010-07-100000-00-00NoNoCurrent