Home NDC 0002-5121-30 Effient
Product NDC 0002-5121
Requested package NDC 0002-5121-30
11-digit product format 000025121
Labeler code 0002
Product ID 0002-5121_6d9c1bbc-8783-4a3d-a487-1868b3c37b14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Eli Lilly and Company
Application NDA022307
Marketing category NDA
Marketing start 2009-07-10
Marketing end 2022-02-28
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 N022307-001 EFFIENT PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 N022307-002 EFFIENT PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10
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 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Prasugrel hydrochloride ACTIVE INGREDIENT G89JQ59I13 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 Prasugrel ACTIVE MOIETY 34K66TBT99 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 GLYCERYL BEHENATE INACTIVE INGREDIENT R8WTH25YS2 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 LACTOSE INACTIVE INGREDIENT J2B2A4N98G EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 SUCROSE STEARATE INACTIVE INGREDIENT 274KW0O50M EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, FILM COATED [ELI LILLY AND COMPANY
] 25
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Effient PRASUGREL HYDROCHLORIDE Cosette Pharmaceuticals, Inc. 69ea2d58-5353-4222-b61f-cab976fa7e5e 2022-09-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022307 application number: NDA022307
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0002-5121-30 00002512130 30 TABLET, FILM COATED in 1 BOTTLE (0002-5121-30) 2012-03-01 2022-02-28 No No Current