Home NDC 68382-200-16 Pramipexole Dihydrochloride
Product NDC 68382-200
Requested package NDC 68382-200-16
11-digit product format 683820200
Labeler code 68382
Product ID 68382-200_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 2 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 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-200 68382-200-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-200 68382-200-16 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 241 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 2026-09-14 22:38:34 2026-08 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078920-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2022-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078920-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078920-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078920-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078920-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-07-06 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 241 observed states.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-200-16 68382020016 90 TABLET in 1 BOTTLE (68382-200-16) 90 tablet 2010-07-10 0000-00-00 No No Current