Home NDC 69844-044-01 PRAMIPEXOLE DIHYDROCHLORIDE
Product NDC 69844-044
Requested package NDC 69844-044-01
11-digit product format 698440044
Labeler code 69844
Product ID 69844-044_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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211088-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2018-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211088-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2018-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211088-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2018-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211088-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2018-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211088-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2018-10-03 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69844-044-01 69844004401 90 TABLET in 1 BOTTLE (69844-044-01) 90 tablet 2020-04-06 0000-00-00 No No Current