Home NDC 60505-3992-8 Clopidogrel
Product NDC 60505-3992
Requested package NDC 60505-3992-8
11-digit product format 605053992
Labeler code 60505
Product ID 60505-3992_2f390e08-7999-65b9-0efa-12c0768eec91
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 2012-05-17
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 90 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 2026-11-14 07:37:17 2026-10 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A076274-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076274-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RS 2014-03-04 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 75 mg/1
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 60505-3992-3 Clopidogrel 30 in 1 BOTTLE TABLET, FILM COATED 30 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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3992 CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.] 25 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 · 3 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 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 Marketing start Status 60505-3992-8 60505399208 39000 TABLET, FILM COATED in 1 PAIL (60505-3992-8) 17-MAY-12 Current