Home NDC 64380-748 pramipexole dihydrochloride
Product NDC 64380-748
11-digit product format 643800748
Labeler code 64380
Product ID 64380-748_94664b38-edd0-4181-8eb2-8bbd9aa3a451
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pramipexole dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA202702
Marketing category ANDA
Marketing start 2021-02-15
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 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 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03
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 · 258 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 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-005 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202702-006 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL AB 2014-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202702-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL AB 2014-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202702-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL AB 2014-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202702-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL AB 2014-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202702-004 PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET / ORAL AB 2014-06-03 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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 .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 64380-748-01 pramipexole dihydrochloride 10 in 1 CARTON TABLET 10 10 64380-748-01 pramipexole dihydrochloride 10 in 1 BLISTER PACK TABLET 10 10 64380-748-05 pramipexole dihydrochloride 90 in 1 BOTTLE TABLET 90 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-748 PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] 10 Current NDC, Legacy NDC, 3 package rows 20211009_fb2260d6-204c-4d25-a331-0f8340d83a6e.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 · 1 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 64380-748-01 64380074801 10 BLISTER PACK in 1 CARTON (64380-748-01) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2021-02-15 0000-00-00 No No Current 64380-748-05 64380074805 90 TABLET in 1 BOTTLE (64380-748-05) 90 tablet 2021-02-15 0000-00-00 No No Current