Clopidogrel

Product NDC
82804-986
11-digit product format
828040986
Labeler code
82804
Product ID
82804-986_330702d9-842c-416d-9b11-b4a9b707e9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clopidogrel Bisulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204165
Marketing category
ANDA
Marketing start
2018-07-27
Substance
CLOPIDOGREL BISULFATE
Active strength
300 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

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOPIDOGREL BISULFATE300 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
749196Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
330702d9-842c-416d-9b11-b4a9b707e9b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39fa80eb-1490-ce82-3d3a-820ae7c37b85Product name520250618
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-986-00Clopidogrel100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
82804-986-30Clopidogrel30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
82804-986-55Clopidogrel500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
82804-986-60Clopidogrel60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
82804-986-64Clopidogrel240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2401
82804-986-72Clopidogrel120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
82804-986-78Clopidogrel180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
82804-986-90Clopidogrel90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-986-00EA - Each82804-986cb737fb9-37eb-4810-aa7a-920f9d1814cf12024-07-12
82804-986-30EA - Each82804-9868bf298e9-21a4-4c1b-ae9f-53f3aae98e9912024-07-12
82804-986-55EA - Each82804-986135a67fe-6938-497c-8e09-35f5c146e4d812024-07-12
82804-986-60EA - Each82804-986e24be14a-27e8-4f9d-abfc-7474f428ef2d12024-07-12
82804-986-64EA - Each82804-986d7021643-9bda-4598-92b2-b04a3ecc37e812024-07-12
82804-986-72EA - Each82804-986f4d6924a-d27a-4938-b38a-1ec65a50c88012024-07-12
82804-986-78EA - Each82804-9865580459a-b1b4-45b8-bc8e-7075413ec92112024-07-12
82804-986-90EA - Each82804-986e154dfb8-1001-4397-ab5c-5c97fd77035512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-986CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 8 package rows20240522_330702d9-842c-416d-9b11-b4a9b707e9b2.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
ndc (product): 82804-986
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 TabletPSN330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG Oral TabletSCD330702d9-842c-416d-9b11-b4a9b707e9b21
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSY330702d9-842c-416d-9b11-b4a9b707e9b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-986-0082804098600100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-00) 2024-05-21NoNoCurrent
82804-986-308280409863030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-30) 2024-05-21NoNoCurrent
82804-986-5582804098655500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-55) 2024-05-21NoNoCurrent
82804-986-608280409866060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-60) 2024-05-21NoNoCurrent
82804-986-6482804098664240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-64) 2024-05-21NoNoCurrent
82804-986-7282804098672120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-72) 2024-05-21NoNoCurrent
82804-986-7882804098678180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-78) 2024-05-21NoNoCurrent
82804-986-908280409869090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-90) 2024-05-21NoNoCurrent