Home NDC 43817-240 PRASUGREL
Product NDC 43817-240
11-digit product format 438170240
Labeler code 43817
Product ID 43817-240_2de10117-c50f-95af-e063-6294a90ab07d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRASUGREL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Panacea Biotec Limited
Application ANDA205897
Marketing category ANDA
Marketing start 2017-10-16
Marketing end 2026-10-31
Substance PRASUGREL HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43817-240-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43817-240-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43817-240-01 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205897-001 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-10-16 A205897-002 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2017-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205897-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205897-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PRASUGREL Active Ingredients# Ingredient, Strength table Ingredient Strength PRASUGREL HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G89JQ59I13 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855812 Internal RxNorm lookup 855818 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43817-240-01 PRASUGREL 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43817-240 PRASUGREL TABLET, FILM COATED [PANACEA BIOTEC LIMITED] 3 Current NDC, Legacy NDC, 1 package rows 20250213_944c195a-de24-a44c-8baa-84b624b5ddcb.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 Marketing start Marketing end Sample Exclude flag Status 43817-240-01 43817024001 30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01) 2017-10-16 2026-10-31 No No Current