Home NDC 31722-908 PRAMIPEXOLE
Product NDC 31722-908
11-digit product format 317220908
Labeler code 31722
Product ID 31722-908_540a17f8-b64d-41e1-a96b-d55bc8c48f3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAMIPEXOLE
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203855
Marketing category ANDA
Marketing start 2015-08-01
Substance PRAMIPEXOLE DIHYDROCHLORIDE
Active strength .5 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 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMIPEXOLE DIHYDROCHLORIDE .5 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 31722-908-05 PRAMIPEXOLE 500 in 1 BOTTLE TABLET 500 4 31722-908-10 PRAMIPEXOLE 1000 in 1 BOTTLE TABLET 1000 4 31722-908-90 PRAMIPEXOLE 90 in 1 BOTTLE TABLET 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMIPEXOLE DIHYDROCHLORIDE ACTIVE INGREDIENT 3D867NP06J PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 PRAMIPEXOLE ACTIVE MOIETY 83619PEU5T PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-908 PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20161129_a7405a56-de1c-4875-b57f-210c991474ba.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 31722-908-05 31722090805 500 TABLET in 1 BOTTLE (31722-908-05) 500 tablet 2015-08-01 0000-00-00 No No Current 31722-908-10 31722090810 1000 TABLET in 1 BOTTLE (31722-908-10) 1000 tablet 2015-08-01 0000-00-00 No No Current 31722-908-90 31722090890 90 TABLET in 1 BOTTLE (31722-908-90) 90 tablet 2015-08-01 0000-00-00 No No Current