PRAMIPEXOLE DIHYDROCHLORIDE

Product NDC
69844-045
11-digit product format
698440045
Labeler code
69844
Product ID
69844-045_b8230032-fa60-4c04-b5e3-6544654cb5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAMIPEXOLE DIHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA211088
Marketing category
ANDA
Marketing start
2020-04-06
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69844-045DDiscontinued by firm2026-08-03
excluded packagepackage69844-04569844-045-01DDiscontinued by firm2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69844-045-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69844-045-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69844-045-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69844-045-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69844-045-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69844-045-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69844-045-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69844-045-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69844-045-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69844-045-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69844-045-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69844-045-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69844-045-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69844-045-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69844-045-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69844-045-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69844-045-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69844-045-01IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211088-001PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-03
A211088-002PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-03
A211088-003PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-03
A211088-004PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-03
A211088-005PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A211088-001AB
A211088-002AB
A211088-003AB
A211088-004AB
A211088-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-001PRAMIPEXOLE DIHYDROCHLORIDE0.25MGTABLET / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-002PRAMIPEXOLE DIHYDROCHLORIDE0.5MGTABLET / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-003PRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-004PRAMIPEXOLE DIHYDROCHLORIDE1MGTABLET / ORALAB2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-005PRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET / ORALAB2018-10-035bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211088-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211088-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211088-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211088-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211088-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211088-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211088-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211088-005AB15bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69844-045-016984400450190 TABLET in 1 BOTTLE (69844-045-01) 90 tablet2020-04-060000-00-00NoNoCurrent