Home NDC 0615-8551 Pramipexole dihydrochloride
Product NDC 0615-8551
11-digit product format 006158551
Labeler code 0615
Product ID 0615-8551_7d36ceb3-2235-42bc-bb8c-e7863c24b1cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pramipexole dihydrochloride
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA090781
Marketing category ANDA
Marketing start 2010-10-08
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength .25 mg/1
Pharmacologic classes Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11
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 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090781-006 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2015-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB RS 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090781-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2010-10-08 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMIPEXOLE DIHYDROCHLORIDE .25 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859040 Internal RxNorm lookup 859044 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 0615-8551-39 Pramipexole dihydrochloride 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8551 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 1 Current NDC, 1 package rows 20241011_5e6f2187-a5cc-481e-b0a1-d38d3f92e822.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0615-8551-39 00615855139 30 TABLET in 1 BLISTER PACK (0615-8551-39) 30 tablet 2024-10-07 No No Current