Clopidogrel bisulfate

Product NDC
67046-099
Requested package NDC
67046-099-28
11-digit product format
670460099
Labeler code
67046
Product ID
67046-099_59b6c299-a9d0-22fd-e053-2a91aa0a6286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076273
Marketing category
ANDA
Marketing start
2017-09-21
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
2020-12-31
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 packagepackage67046-09967046-099-28IInactivated 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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A076273-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076273-001AB

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 06:07:402026-07A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-143f01610625f2…
2019-09-15 20:21 UTC2019-09A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076273-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2008-01-14e64feba35796…

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 06:07:402026-07A076273-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076273-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076273-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076273-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076273-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076273-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076273-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076273-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076273-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076273-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076273-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076273-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076273-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076273-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076273-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076273-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076273-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076273-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076273-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076273-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076273-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076273-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076273-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076273-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076273-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076273-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076273-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076273-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076273-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076273-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076273-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076273-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076273-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076273-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076273-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076273-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076273-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076273-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076273-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076273-001AB1e64feba35796…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67046-099-07099 Clopidogrel 75 mg These 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
67046-099-14099 Clopidogrel 75 mg These 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
67046-099-15099 Clopidogrel 75 mg These 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
67046-099-20099 Clopidogrel 75 mg These 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
67046-099-21099 Clopidogrel 75 mg These 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
67046-099-28099 Clopidogrel 75 mg These 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
67046-099-30099 Clopidogrel 75 mg These 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
67046-099-60099 Clopidogrel 75 mg These 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
67046-099-07Clopidogrel bisulfate7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-099-14Clopidogrel bisulfate14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-099-15Clopidogrel bisulfate15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-099-20Clopidogrel bisulfate20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-099-21Clopidogrel bisulfate21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-099-28Clopidogrel bisulfate28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-099-30Clopidogrel bisulfate30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-099-60Clopidogrel bisulfate60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-099CLOPIDOGREL BISULFATE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b6c299-a9cf-22fd-e053-2a91aa0a6286.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clopidogrel bisulfateCLOPIDOGREL BISULFATEQuallent Pharmaceuticals Health LLC333c7992-d481-b7d4-404f-9a49c85b63312025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076273
application number: ANDA076273
Clopidogrel bisulfateCLOPIDOGREL BISULFATEDr.Reddy's Laboratories Limitedb5aa951f-72de-bea1-98a2-a4085c64a3612025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076273
application number: ANDA076273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN59b6c299-a9cf-22fd-e053-2a91aa0a62861
309362clopidogrel 75 MG Oral TabletSCD59b6c299-a9cf-22fd-e053-2a91aa0a62861
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY59b6c299-a9cf-22fd-e053-2a91aa0a62861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-099-286704600992828 TABLET, FILM COATED in 1 BLISTER PACK (67046-099-28) 2017-09-210000-00-00NoNoCurrent