Clopidogrel

Product NDC
53002-1672
Requested package NDC
53002-1672-0
11-digit product format
530021672
Labeler code
53002
Product ID
53002-1672_09fa4a76-071b-4364-964a-c6e9be0f812d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-167253002-1672-0IInactivated by FDA2026-08-17

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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090540-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090540-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173f01610625f2…
2019-09-15 20:21 UTC2019-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090540-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-05-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090540-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090540-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090540-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090540-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090540-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090540-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090540-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090540-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090540-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090540-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090540-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090540-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090540-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090540-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090540-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090540-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090540-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090540-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090540-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090540-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090540-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090540-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090540-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090540-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090540-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090540-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090540-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090540-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090540-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090540-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090540-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090540-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090540-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090540-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090540-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090540-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090540-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090540-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090540-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090540-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53002-1672-02025-01-30These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-32025-01-30These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-02023-06-08These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-32023-06-08These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-02023-01-30These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-32023-01-30These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-02020-12-15These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-32020-12-15These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-02020-01-31These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
53002-1672-32020-01-31These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1672-0Clopidogrel100 in 1 BOTTLETABLET, FILM COATED1005
53002-1672-3Clopidogrel30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1672CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_5da7468b-b829-4624-b84d-84bdebf61a0d.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClopidogrelCLOPIDOGREL BISULFATEREMEDYREPACK INC.3e2539c1-a6ad-4d60-944c-c2e7aa70ce452026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATELegacy Pharmaceutical Packaging, LLC53de10a5-dbd0-413d-90e5-00a1920ec3912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.553b4938-4462-4aeb-e054-00144ff88e882026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.55530ff3-5ce4-120f-e054-00144ff8d46c2026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEPD-Rx Pharmaceuticals, Inc.20247bf8-30ec-4807-95c1-8ec7587368ae2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEA-S Medication Solutionse19174f4-ec3c-4cd6-ad7d-d1e882f9d7b42024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEBryant Ranch Prepacke8f98886-4771-4be3-8b57-edfbbc1b46612024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEAurobindo Pharma Limited0078fb3d-3595-4ae1-a059-1d5e81c879cf2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEA-S Medication Solutionsb6e6a9b8-bf91-4e7f-b872-880afb5584262023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540
ClopidogrelCLOPIDOGREL BISULFATEProficient Rx LPec296eed-81d0-4c1e-bff4-4318518991572022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090540
application number: ANDA090540

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN5da7468b-b829-4624-b84d-84bdebf61a0d5
309362clopidogrel 75 MG Oral TabletSCD5da7468b-b829-4624-b84d-84bdebf61a0d5
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY5da7468b-b829-4624-b84d-84bdebf61a0d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1672-053002167200100 TABLET, FILM COATED in 1 BOTTLE (53002-1672-0) 2018-10-010000-00-00NoNoCurrent