Clopidogrel

Product NDC
55648-315
11-digit product format
556480315
Labeler code
55648
Product ID
55648-315_79a0b285-80de-4b38-9d3f-37fb165ef36b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA202266
Marketing category
ANDA
Marketing start
2012-11-13
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
E
Listing certified through
2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-315IInactivated by FDA2026-08-07
excluded packagepackage55648-31555648-315-00IInactivated by FDA2026-08-07
excluded packagepackage55648-31555648-315-01IInactivated by FDA2026-08-07
excluded packagepackage55648-31555648-315-02IInactivated by FDA2026-08-07
excluded packagepackage55648-31555648-315-04IInactivated by FDA2026-08-07

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 · 110 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 packagepackage55648-315-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-315-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-315-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-315-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-315-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-315-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-315-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-315-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-315-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-315-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-315-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-315-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-315-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-315-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-315-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-315-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-315-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-315-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-315-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-315-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-315-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-315-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-315-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-315-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-315-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-315-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-315-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-315-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-315-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-315-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-315-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-315-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-315-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-315-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-315-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-315-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-315-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-315-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-315-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-315-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-315-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-315-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-315-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-315-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-315-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-315-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-315-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-315-00557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202266-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14
A202266-002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2012-08-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2012-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202266-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-08-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A202266-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORAL2012-11-20782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A202266-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202266-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A202266-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202266-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202266-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202266-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202266-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202266-002AB1ea99ee380514…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-315-00Clopidogrel1500 in 1 POUCHTABLET, FILM COATED15002
55648-315-01Clopidogrel30 in 1 BOTTLETABLET, FILM COATED302
55648-315-02Clopidogrel90 in 1 BOTTLETABLET, FILM COATED902
55648-315-04Clopidogrel10 in 1 CARTONTABLET, FILM COATED102
55648-315-04Clopidogrel10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOPIDOGREL BISULFATEACTIVE INGREDIENT08I79HTP27CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
CLOPIDOGRELACTIVE MOIETYA74586SNO7CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WECLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-315CLOPIDOGREL TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 5 package rows20121113_de099108-7445-4632-b85f-93a1bc05adf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG Oral TabletPSNde099108-7445-4632-b85f-93a1bc05adf02
749196clopidogrel 300 MG Oral TabletSCDde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG Oral TabletSCDde099108-7445-4632-b85f-93a1bc05adf02
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYde099108-7445-4632-b85f-93a1bc05adf02
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYde099108-7445-4632-b85f-93a1bc05adf02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-315-00556480315001500 in 1 POUCHHistorical
55648-315-015564803150130 in 1 BOTTLEHistorical
55648-315-025564803150290 in 1 BOTTLEHistorical
55648-315-045564803150410 in 1 CARTONHistorical