Home NDC 60505-3532 Clopidogrel
Product NDC 60505-3532
11-digit product format 605053532
Labeler code 60505
Product ID 60505-3532_936a8707-dc3c-ebe4-6a66-0f726988c764
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA076274
Marketing category ANDA
Marketing start 2014-03-04
Substance CLOPIDOGREL BISULFATE
Active strength 300 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 · 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 · 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 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…2022-03-09 01:35 UTC 2022-03 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clopidogrel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 300 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309362 Internal RxNorm lookup 749196 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 60505-3532-5 Clopidogrel 500 in 1 BOTTLE TABLET, FILM COATED 500 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 Hydroxypropyl Cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 METHYLCELLULOSE (15 CPS) INACTIVE INGREDIENT NPU9M2E6L8 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 9 CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYDROXYPROPYL CELLULOSE (TYPE E) INACTIVE INGREDIENT 66O7AQV0RT CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 METHYLCELLULOSE (15 MPA.S) INACTIVE INGREDIENT NPU9M2E6L8 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 METHYLCELLULOSE (15 MPA.S) INACTIVE INGREDIENT NPU9M2E6L8 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3532 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 25 Current NDC, Legacy NDC, 1 package rows 20240925_edae8df1-caf9-ff72-1304-5ae8b355f8e7.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 · 5 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 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 ndc (product): 60505-3532 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 American Health Packaging 65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 2025-01-21 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 Marketing start Marketing end Sample Exclude flag Status 60505-3532-5 60505353205 500 TABLET, FILM COATED in 1 BOTTLE (60505-3532-5) 2014-03-04 0000-00-00 No No Current