Home NDC 60429-085 Pramipexole Dihydrochloride
Product NDC 60429-085
11-digit product format 604290085
Labeler code 60429
Product ID 60429-085_494fcbc6-e427-a591-e063-6394a90ae5df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pramipexole Dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA203855
Marketing category ANDA
Marketing start 2014-10-28
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength .125 mg/1
Pharmacologic classes Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28
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 · 252 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 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203855-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203855-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203855-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203855-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203855-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-10-28 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pramipexole Dihydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3D867NP06J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858625 Internal RxNorm lookup 859033 Internal RxNorm lookup 859040 Internal RxNorm lookup 859044 Internal RxNorm lookup 859048 Internal RxNorm lookup 859052 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60429-085-90 Pramipexole Dihydrochloride 90 in 1 BOTTLE TABLET 90 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMIPEXOLE DIHYDROCHLORIDE ACTIVE INGREDIENT 3D867NP06J PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 PRAMIPEXOLE ACTIVE MOIETY 83619PEU5T PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-085 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20250509_f8ac759f-59fb-49e4-a772-4114facdaea3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-085-90 60429008590 90 TABLET in 1 BOTTLE (60429-085-90) 90 tablet 2025-04-07 0000-00-00 No No Current