Clopidogrel bisulfate

Product NDC
71399-7500
11-digit product format
713997500
Labeler code
71399
Product ID
71399-7500_45e4ee6a-f309-46d3-800a-30a52cfac2f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Akron Pharma Inc
Application
ANDA204165
Marketing category
ANDA
Marketing start
2018-05-23
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71399-7500DDiscontinued by firm2026-08-17
excluded packagepackage71399-750071399-7500-1DDiscontinued by firm2026-08-17
excluded packagepackage71399-750071399-7500-2DDiscontinued by firm2026-08-17
excluded packagepackage71399-750071399-7500-3DDiscontinued by firm2026-08-17
excluded packagepackage71399-750071399-7500-5DDiscontinued by firm2026-08-17
excluded packagepackage71399-750071399-7500-9DDiscontinued 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 2 · 84 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 packagepackage71399-7500-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71399-7500-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71399-7500-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71399-7500-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71399-7500-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71399-7500-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71399-7500-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71399-7500-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71399-7500-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71399-7500-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71399-7500-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71399-7500-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71399-7500-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71399-7500-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71399-7500-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71399-7500-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71399-7500-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71399-7500-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71399-7500-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71399-7500-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71399-7500-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71399-7500-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71399-7500-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71399-7500-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71399-7500-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71399-7500-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71399-7500-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71399-7500-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71399-7500-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71399-7500-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71399-7500-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71399-7500-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71399-7500-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71399-7500-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71399-7500-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71399-7500-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71399-7500-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71399-7500-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71399-7500-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71399-7500-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71399-7500-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71399-7500-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71399-7500-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71399-7500-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71399-7500-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71399-7500-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71399-7500-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71399-7500-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71399-7500-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71399-7500-5ad56d346431e…cc804d4bbf1e…

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
A204165-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15
A204165-002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204165-001AB
A204165-002AB

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 06:07:402026-07A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204165-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204165-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204165-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204165-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204165-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204165-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204165-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204165-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204165-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204165-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204165-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204165-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204165-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204165-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204165-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204165-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204165-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204165-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-7500-12021-05-06These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-22021-05-06These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-32021-05-06These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-52021-05-06These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-92021-05-06These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-12020-01-31These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-22020-01-31These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-32020-01-31These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-52020-01-31These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997
71399-7500-92020-01-31These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-7500-5EA - Each71399-75001f07b98a-6a15-40a4-98de-df2b28a7f00312018-08-13

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clopidogrel bisulfateCLOPIDOGREL BISULFATEPreferred Pharmaceuticals, Inc.e51d4bcc-01df-409d-9179-45e6536ac25b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATENCS HealthCare of KY, LLC dba Vangard Labs8406b8e3-e203-402f-8858-2748119e23512026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ClopidogrelCLOPIDOGREL BISULFATEAvPAK94a5cdc4-e063-1d46-e053-2995a90a7e152026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEREMEDYREPACK INC.2969deac-274b-4042-9c90-9522e62a979d2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.a7bf847d-43e9-166e-e053-2995a90a239e2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ClopidogrelCLOPIDOGREL BISULFATEProficient Rx LP330702d9-842c-416d-9b11-b4a9b707e9b22024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEBryant Ranch Prepack539265a6-e356-42cd-bde9-ac704f108c742024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATERADHA PHARMACEUTICALS, INC.16aef4f6-6b90-4d5f-9e07-c9927adf38412023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEBryant Ranch Prepack7c4b3bc3-8f3b-4232-835d-e37d93b92c3e2023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEScieGen Pharmaceuticals Incd03cfc18-c9e4-41f8-b54d-6a7564c32afb2023-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ClopidogrelCLOPIDOGREL BISULFATEWestminster Pharmaceuticals, LLCbb3b5e96-e629-4db5-8ad5-40c17c6dae182023-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEProficient Rx LP4842be24-3919-48ae-9302-eb9d3d9212242019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ClopidogrelCLOPIDOGRELVensun Pharmaceuticals, Inc.86ee71f2-850e-4c8e-87f3-c7a618d59d952019-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165