Home NDC 16729-272 Prasugrel
Product NDC 16729-272
11-digit product format 167290272
Labeler code 16729
Product ID 16729-272_0e2f030a-d262-a36c-e063-6294a90a40ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA205987
Marketing category ANDA
Marketing start 2019-01-16
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 A205987-001 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-02-02 A205987-002 PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-02-02
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 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205987-001 PRASUGREL EQ 5MG BASE TABLET / ORAL AB 2018-02-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205987-002 PRASUGREL EQ 10MG BASE TABLET / ORAL AB 2018-02-02 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 16729-272-10 Prasugrel 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-272 PRASUGREL TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 7 Current NDC, Legacy NDC, 1 package rows 20240106_cd6bf899-06b7-4f52-96c5-ffc94a7288ff.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 16729-272-10 16729027210 30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10) 2019-01-16 0000-00-00 No No Current