Clopidogrel

Product NDC
16729-219
11-digit product format
167290219
Labeler code
16729
Product ID
16729-219_d481c0f7-ad3d-c647-e053-2a95a90ac06c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202925
Marketing category
ANDA
Marketing start
2015-01-08
Marketing end
0000-00-00
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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
2023-12-31
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 productproduct16729-219DDiscontinued by firm2026-08-17
excluded packagepackage16729-21916729-219-46DDiscontinued by firm2026-08-17
excluded packagepackage16729-21916729-219-75DDiscontinued 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 · 36 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 packagepackage16729-219-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-219-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-219-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-219-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-219-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-219-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-219-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-219-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-219-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-219-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-219-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-219-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-219-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-219-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-219-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-219-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-219-460efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-219-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-219-46ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-219-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-219-46367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-219-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-219-46557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-219-75557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202925-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27
A202925-002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2013-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2013-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202925-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2013-03-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202925-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2013-03-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A202925-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202925-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202925-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202925-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202925-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202925-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202925-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202925-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202925-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202925-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202925-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202925-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202925-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202925-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202925-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202925-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202925-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202925-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202925-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202925-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202925-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202925-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202925-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202925-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202925-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202925-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202925-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202925-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202925-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202925-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202925-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A202925-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202925-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A202925-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202925-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202925-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202925-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202925-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202925-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202925-002AB1a67488948f0b…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-219-46EA - Each16729-21999e3d0af-e734-4979-b76b-b781da810b8812013-08-02
16729-219-75EA - Each16729-219ad72a596-5409-4e49-96b2-f424e26d2b4612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-219-751672902197530 BLISTER PACK in 1 CARTON (16729-219-75) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2015-01-080000-00-00NoNoCurrent