Home NDC 51407-247-30 Prasugrel
Product NDC 51407-247
Requested package NDC 51407-247-30
11-digit product format 514070247
Labeler code 51407
Product ID 51407-247_dc7991c8-6d60-2f59-e053-2a95a90acfdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA205897
Marketing category ANDA
Marketing start 2017-10-16
Marketing end 2022-06-30
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51407-247-30 51407024730 30 TABLET, FILM COATED in 1 BOTTLE (51407-247-30) 2020-01-17 2022-06-30 No No Current