Home NDC 68462-627 Pramipexole dihydrochloride
Product NDC 68462-627
11-digit product format 684620627
Labeler code 68462
Product ID 68462-627_75644134-fcad-4dde-8a22-453d18472002
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pramipexole dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090781
Marketing category ANDA
Marketing start 2016-01-31
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength .75 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 .75 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 68462-627-05 Pramipexole dihydrochloride 500 in 1 BOTTLE TABLET 500 13 68462-627-90 Pramipexole dihydrochloride 90 in 1 BOTTLE TABLET 90 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMIPEXOLE DIHYDROCHLORIDE ACTIVE INGREDIENT 3D867NP06J PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 PRAMIPEXOLE ACTIVE MOIETY 83619PEU5T PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-627 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 2 package rows 20240104_44c336d2-01d1-4f13-bad9-549cdc3505ec.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 Marketing end Sample Exclude flag Status 68462-627-05 68462062705 500 TABLET in 1 BOTTLE (68462-627-05) 500 tablet 2016-01-31 0000-00-00 No No Current 68462-627-90 68462062790 90 TABLET in 1 BOTTLE (68462-627-90) 90 tablet 2016-01-31 0000-00-00 No No Current