Home NDC 65862-829 Prasugrel
Product NDC 65862-829
11-digit product format 658620829
Labeler code 65862
Product ID 65862-829_ad62076d-f75e-4cfa-b68f-3e873f244bcb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA205888
Marketing category ANDA
Marketing start 2017-10-16
Substance PRASUGREL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205888-001 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2017-10-16 A205888-002 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 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205888-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2017-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205888-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2017-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205888-002 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRASUGREL HYDROCHLORIDE 5 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-829-03 Prasugrel 3 in 1 CARTON TABLET, FILM COATED 3 11 65862-829-10 Prasugrel 10 in 1 BLISTER PACK TABLET, FILM COATED 10 11 65862-829-30 Prasugrel 30 in 1 BOTTLE TABLET, FILM COATED 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-829 PRASUGREL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 Current NDC, Legacy NDC, 3 package rows 20240202_596c923d-db8d-4b96-bf31-52186a38c30d.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 65862-829-03 65862082903 3 BLISTER PACK in 1 CARTON (65862-829-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10) 3 blister pack 2017-10-16 0000-00-00 No No Current 65862-829-10 65862082910 10 in 1 BLISTER PACK Historical 65862-829-30 65862082930 30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30) 2017-10-16 0000-00-00 No No Current