Home NDC 0713-0882 Effient
Product NDC 0713-0882
11-digit product format 007130882
Labeler code 0713
Product ID 0713-0882_e8172297-af81-4c37-e053-2995a90ad4e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prasugrel Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA022307
Marketing category NDA
Marketing start 2022-09-01
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 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# Additional Listing Data#
Finished product Yes
Brand name base Effient
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855812 Internal RxNorm lookup 855816 Internal RxNorm lookup 855818 Internal RxNorm lookup 855820 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0882-30 Effient 30 in 1 BOTTLE TABLET, COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0882 EFFIENT (PRASUGREL HYDROCHLORIDE) TABLET, COATED [COSETTE PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20220909_69ea2d58-5353-4222-b61f-cab976fa7e5e.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.
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 ndc (product): 0713-0882
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 0713-0882-30 00713088230 30 TABLET, COATED in 1 BOTTLE (0713-0882-30) 2022-09-01 0000-00-00 No No Current