Home NDC 70518-4373 CLOPIDOGREL
Product NDC 70518-4373
11-digit product format 705184373
Labeler code 70518
Product ID 70518-4373_388cc422-27df-293f-e063-6394a90a2772
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOPIDOGREL BISULFATE
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA203632
Marketing category ANDA
Marketing start 2025-06-26
Substance CLOPIDOGREL BISULFATE
Active strength 75 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203632-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203632-001 AB
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.
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 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203632-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-12-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CLOPIDOGREL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 08I79HTP27 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309362 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 70518-4373-0 CLOPIDOGREL 90 in 1 BOTTLE, PLASTIC TABLET 90 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOPIDOGREL CLOPIDOGREL BISULFATE Ascend Laboratories, LLC db1161c9-6efd-4361-a766-6a37c241ccee 2026-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203632 application number: ANDA203632 CLOPIDOGREL CLOPIDOGREL BISULFATE REMEDYREPACK INC. 669f0bc6-f173-484d-8efe-c006683b25d1 2025-06-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203632 application number: ANDA203632 ndc (product): 70518-4373 CLOPIDOGREL CLOPIDOGREL BISULFATE A-S Medication Solutions ffeb2fca-d475-4d93-913d-0048ff9fcee9 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203632 application number: ANDA203632 CLOPIDOGREL CLOPIDOGREL BISULFATE A-S Medication Solutions 2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203632 application number: ANDA203632
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4373-0 70518437300 90 TABLET in 1 BOTTLE, PLASTIC (70518-4373-0) 90 tablet 2025-06-26 No No Current