Pramipexole Dihydrochloride

Product NDC
68084-982
11-digit product format
680840982
Labeler code
68084
Product ID
68084-982_8c61d729-56a1-775a-e053-2a95a90aed5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pramipexole Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078920
Marketing category
ANDA
Marketing start
2015-03-31
Marketing end
2020-08-31
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68084-982DDiscontinued by firm2026-09-14
excluded productproduct68084-982DDiscontinued by firm2026-09-14
excluded packagepackage68084-98268084-982-21DDiscontinued by firm2026-09-14
excluded packagepackage68084-98268084-982-25DDiscontinued by firm2026-09-14
excluded packagepackage68084-98268084-982-25DDiscontinued 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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-982-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-982-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-982-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-982-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-982-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-982-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-982-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-982-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-982-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-982-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-982-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-982-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-982-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-982-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-982-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-982-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-982-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-982-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-982-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-982-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-982-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-982-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-982-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-982-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-982-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-982-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-982-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-982-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-982-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-982-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-982-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-982-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-982-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-982-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-982-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-982-21557ba5c1ecfa…9c80585c8c6e…

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
68084-982-25EA - Each68084-982b673c057-ecc5-4378-8613-0fef559f055612015-10-02
68084-982-95EA - Each68084-982ad4e0a1f-6a88-4c06-8b7c-c024f8a8011612015-10-02

DailyMed Socrata Ingredients#