Clopidogrel

Product NDC
68071-4023
11-digit product format
680714023
Labeler code
68071
Product ID
68071-4023_4bacf812-11f9-22e6-e063-6294a90a5fb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090540
Marketing category
ANDA
Marketing start
2012-05-17
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

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-4023-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-4023-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-4023-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-4023-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-4023-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-4023-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-4023-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-4023-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-4023-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-4023-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-4023-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4023-3557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08I79HTP27Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55530ff3-5ce4-120f-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4023-3Clopidogrel30 in 1 BOTTLETABLET, FILM COATED304

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
ndc (product): 68071-4023
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 TabletPSN55530ff3-5ce4-120f-e054-00144ff8d46c4
309362clopidogrel 75 MG Oral TabletSCD55530ff3-5ce4-120f-e054-00144ff8d46c4
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY55530ff3-5ce4-120f-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-4023-36807140230330 TABLET, FILM COATED in 1 BOTTLE (68071-4023-3) 2017-07-27NoNoCurrent