Home NDC 68788-4173 CLOPIDOGREL
Product NDC 68788-4173
11-digit product format 687884173
Labeler code 68788
Product ID 68788-4173_c9928956-bb7b-4ec2-bc38-d3c9c4199cae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOPIDOGREL BISULFATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA215388
Marketing category ANDA
Marketing start 2026-07-24
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215388-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215388-001 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 2026-09-14 22:38:34 2026-08 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215388-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-09-20 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CLOPIDOGREL
Listing expiration 2027-12-31 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.
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 Sample Exclude flag Status 68788-4173-3 68788417303 30 TABLET, FILM COATED in 1 BOTTLE (68788-4173-3) 2026-07-24 No No Current 68788-4173-6 68788417306 60 TABLET, FILM COATED in 1 BOTTLE (68788-4173-6) 2026-07-24 No No Current 68788-4173-9 68788417309 90 TABLET, FILM COATED in 1 BOTTLE (68788-4173-9) 2026-07-24 No No Current