Clopidogrel bisulfate

Product NDC
62034-017
11-digit product format
620340017
Labeler code
62034
Product ID
62034-017_74b235fb-7b6d-4d07-ba6e-3bca30e847c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2016-03-01
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
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62034-017IInactivated by FDA2026-08-17
excluded packagepackage62034-01762034-017-73IInactivated 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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62034-017-73IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62034-017-73IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62034-017-73IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62034-017-73IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62034-017-73IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62034-017-73IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62034-017-73IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62034-017-73IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62034-017-73IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62034-017-73IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62034-017-73IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62034-017-73IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62034-017-73IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62034-017-73IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62034-017-73IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62034-017-73IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62034-017-73IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62034-017-73IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62034-017-73IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62034-017-73IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62034-017-73IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62034-017-73EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

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
62034-017-11Clopidogrel bisulfate1 in 1 BLISTER PACKTABLET, FILM COATED11
62034-017-73Clopidogrel bisulfate30 in 1 BOX, UNIT-DOSETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62034-017CLOPIDOGREL BISULFATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20160301_994dc0b4-0158-45db-965f-db827296f619.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSN994dc0b4-0158-45db-965f-db827296f6191
749196clopidogrel 300 MG Oral TabletSCD994dc0b4-0158-45db-965f-db827296f6191
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY994dc0b4-0158-45db-965f-db827296f6191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62034-017-11620340017111 in 1 BLISTER PACKHistorical
62034-017-736203400177330 in 1 BOX, UNIT-DOSEHistorical