Clopidogrel bisulfate

Product NDC
68071-5277
11-digit product format
680715277
Labeler code
68071
Product ID
68071-5277_1d7904db-ccb2-b88e-e063-6294a90ac568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204165
Marketing category
ANDA
Marketing start
2015-09-15
Substance
CLOPIDOGREL BISULFATE
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68071-5277-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68071-5277-9bd6a592717d7…303034d00443…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Clopidogrel bisulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08I79HTP27Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7bf847d-43e9-166e-e053-2995a90a239eAvailable on FDA.report

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
68071-5277-9Clopidogrel bisulfate90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5277CLOPIDOGREL BISULFATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]21Current NDC, Legacy NDC, 1 package rows20240719_a7bf847d-43e9-166e-e053-2995a90a239e.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
ndc (product): 68071-5277
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
309362clopidogrel 75 MG Oral TabletPSNa7bf847d-43e9-166e-e053-2995a90a239e21
309362clopidogrel 75 MG Oral TabletSCDa7bf847d-43e9-166e-e053-2995a90a239e21
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYa7bf847d-43e9-166e-e053-2995a90a239e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5277-96807152770990 TABLET, FILM COATED in 1 BOTTLE (68071-5277-9) 2020-06-100000-00-00NoNoCurrent