Home NDC 65162-002 Prasugrel
Product NDC 65162-002
11-digit product format 651620002
Labeler code 65162
Product ID 65162-002_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA205913
Marketing category ANDA
Marketing start 2018-06-22
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
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 A205913-001 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-06-19 A205913-002 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-06-19
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 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL 2018-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL 2018-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL 2018-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL 2018-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL BX 2018-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL BX 2018-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL BX 2018-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL BX 2018-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL BX 2018-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL BX 2018-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-06-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205913-001 PRASUGREL EQ 5MG BASE TABLET / ORAL BX 2018-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205913-002 PRASUGREL EQ 10MG BASE TABLET / ORAL BX 2018-06-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-002-03 Prasugrel 30 in 1 BOTTLE TABLET, FILM COATED 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-002 PRASUGREL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 1 package rows 20240711_406cc201-89b6-43cc-9e14-a59327a5b4d8.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 Marketing start Marketing end Sample Exclude flag Status 65162-002-03 65162000203 30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03) 2018-06-22 0000-00-00 No No Current