Clopidogrel

Product NDC
70518-1898
11-digit product format
705181898
Labeler code
70518
Product ID
70518-1898_4987afa4-e527-4ae3-e063-6394a90aa694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090540
Marketing category
ANDA
Marketing start
2019-02-22
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-189870518-1898-1DDiscontinued by firm2026-08-17
excluded packagepackage70518-189870518-1898-2DDiscontinued by firm2026-08-17

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 · 13 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-1898-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-1898-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-1898-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-1898-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-1898-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-1898-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-1898-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-1898-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-1898-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-1898-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-1898-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-1898-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-1898-0557ba5c1ecfa…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
3e2539c1-a6ad-4d60-944c-c2e7aa70ce45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1898-0Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1898-1Clopidogrel30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1898-2Clopidogrel90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1898CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 3 package rows20250302_3e2539c1-a6ad-4d60-944c-c2e7aa70ce45.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
ndc (product): 70518-1898
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 TabletPSN3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514
309362clopidogrel 75 MG Oral TabletSCD3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY3e2539c1-a6ad-4d60-944c-c2e7aa70ce4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1898-07051818980030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1898-0) 2019-02-22NoNoCurrent
70518-1898-17051818980130 in 1 BLISTER PACKHistorical
70518-1898-27051818980290 in 1 BOTTLE, PLASTICHistorical