Clopidogrel

Product NDC
76519-1016
11-digit product format
765191016
Labeler code
76519
Product ID
76519-1016_5df77934-8584-0707-e053-2991aa0a52e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company Inc
Application
ANDA202928
Marketing category
ANDA
Marketing start
2017-11-06
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
2019-12-31
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 productproduct76519-1016IInactivated by FDA2026-08-17
excluded packagepackage76519-101676519-1016-2IInactivated by FDA2026-08-17
excluded packagepackage76519-101676519-1016-3IInactivated 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 2 · 63 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 packagepackage76519-1016-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76519-1016-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1016-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1016-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1016-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1016-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1016-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1016-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1016-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1016-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1016-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1016-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1016-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1016-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1016-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1016-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1016-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1016-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1016-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1016-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1016-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1016-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1016-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1016-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76519-1016-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76519-1016-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76519-1016-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76519-1016-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76519-1016-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76519-1016-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76519-1016-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76519-1016-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76519-1016-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76519-1016-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76519-1016-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76519-1016-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76519-1016-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76519-1016-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76519-1016-3e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76519-1016-2e2bbac7714bc…27bdfed8d636…

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
A202928-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202928-001AB

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 06:07:402026-07A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-103f01610625f2…
2019-09-15 20:21 UTC2019-09A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202928-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-02-10e64feba35796…

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 06:07:402026-07A202928-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202928-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202928-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202928-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202928-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202928-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202928-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202928-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202928-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202928-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202928-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202928-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202928-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202928-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202928-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202928-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202928-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202928-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202928-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202928-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202928-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202928-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202928-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202928-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202928-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202928-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202928-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202928-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202928-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202928-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202928-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202928-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202928-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202928-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202928-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202928-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202928-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202928-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202928-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202928-001AB1e64feba35796…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1016-22020-01-31C16284748780-19d75b9d0-c66d-f424-e053-dadaa90a57ce5df77934-8583-0707-e053-2991aa0a52e5
76519-1016-32020-01-31C16284748780-19d75b9d0-c66d-f424-e053-dadaa90a57ce5df77934-8583-0707-e053-2991aa0a52e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1016-2Clopidogrel200 in 1 CONTAINERTABLET2001
76519-1016-3Clopidogrel30 in 1 CONTAINERTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1016CLOPIDOGREL TABLET [H.J. HARKINS COMPANY INC]1Legacy NDC, 2 package rows20171122_5df77934-8583-0707-e053-2991aa0a52e5.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClopidogrelCLOPIDOGRELRedpharm Drug55731d95-0c99-ff61-e063-6394a90a1ab52026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELNorthStar RxLLCd176de1d-b1b3-4aa9-b783-d53f65a79e502024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELA-S Medication Solutions02f0eaf8-0fc2-425d-8259-cef00156e25d2024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELA-S Medication Solutions3aef6fd4-7160-4678-9362-ca76174bfd0e2024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELA-S Medication Solutions3c8c68ca-aa48-43f0-977d-2608e1666be42024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELBryant Ranch Prepack85df051d-0fa9-41b3-8862-9d6ca851a9cc2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928
ClopidogrelCLOPIDOGRELMacleods Pharmaceuticals Limited063cd1eb-98fd-422e-8145-bba04c497efe2024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202928
application number: ANDA202928

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309362clopidogrel 75 MG Oral TabletPSN5df77934-8583-0707-e053-2991aa0a52e51
309362clopidogrel 75 MG Oral TabletSCD5df77934-8583-0707-e053-2991aa0a52e51
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSY5df77934-8583-0707-e053-2991aa0a52e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1016-276519101602200 in 1 CONTAINERHistorical
76519-1016-37651910160330 in 1 CONTAINERHistorical