Clopidogrel

Product NDC
50436-9986
11-digit product format
504369986
Labeler code
50436
Product ID
50436-9986_d2f13046-b901-4b53-a3d0-76fb752a2768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-9986IInactivated by FDA2026-08-17
excluded packagepackage50436-998650436-9986-1IInactivated by FDA2026-08-17
excluded packagepackage50436-998650436-9986-3IInactivated 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 · 57 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 packagepackage50436-9986-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-9986-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-9986-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-9986-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-9986-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-9986-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-9986-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-9986-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-9986-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-9986-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-9986-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-9986-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-9986-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-9986-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-9986-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-9986-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-9986-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-9986-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-9986-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-9986-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-9986-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-9986-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-9986-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-9986-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-9986-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-9986-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-9986-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-9986-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-9986-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-9986-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-9986-1fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-9986-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-9986-186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-9986-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-9986-1bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-9986-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-9986-18dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-9986-38dfbde2a14a4…c9ff85d89658…

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9986-1Clopidogrel30 in 1 BOTTLETABLET, FILM COATED3011
50436-9986-3Clopidogrel90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9986CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [UNIT DOSE SERVICES]11Legacy NDC, 2 package rows20171109_2ed86bc8-8ea5-4ffa-a762-4fc266c1e620.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 TabletPSN2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011
309362clopidogrel 75 MG Oral TabletSCD2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY2ed86bc8-8ea5-4ffa-a762-4fc266c1e62011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9986-15043699860130 in 1 BOTTLEHistorical
50436-9986-35043699860390 in 1 BOTTLEHistorical