Home NDC 55154-2149 Clopidogrel
Product NDC 55154-2149
11-digit product format 551542149
Labeler code 55154
Product ID 55154-2149_f2c8b1d7-dfbb-488c-b554-3b2d685fd6b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel Bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA076274
Marketing category ANDA
Marketing start 2025-10-10
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076274-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 A076274-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04
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 · 86 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 2026-09-14 22:38:34 2026-08 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2014-03-04 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-2149-0 Clopidogrel 1 in 1 BLISTER PACK TABLET, FILM COATED 1 3 55154-2149-0 Clopidogrel 10 in 1 BAG TABLET, FILM COATED 10 3
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 Cardinal Health 107, LLC c03a895c-2d74-4d7f-891f-b752ce409b68 2026-04-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 55154-2149 Clopidogrel CLOPIDOGREL BISULFATE Apotex Corp. edae8df1-caf9-ff72-1304-5ae8b355f8e7 2025-09-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274 Clopidogrel CLOPIDOGREL BISULFATE Major Pharmaceuticals 4cd07a3c-9673-4aa0-b76a-d79df2399ee1 2025-09-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274 Clopidogrel CLOPIDOGREL BISULFATE Aphena Pharma Solutions - Tennessee, LLC d49362ae-f78a-47d8-ac14-8262d621fcaa 2021-03-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076274 application number: ANDA076274
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55154-2149-0 55154214900 10 BLISTER PACK in 1 BAG (55154-2149-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2025-10-10 No No Current