Plavix

Product NDC
0024-1171
11-digit product format
000241171
Labeler code
0024
Product ID
0024-1171_ed60a9e7-49f4-469c-bb7a-08e1bb6057e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clopidogrel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020839
Marketing category
NDA
Marketing start
1997-11-17
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

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
N020839-001PLAVIXCLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALABRLD1997-11-17
N020839-002PLAVIXCLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALABRLD2007-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020839-001AB
N020839-002AB

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 06:07:402026-07N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD, RS2007-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020839-001PLAVIXEQ 75MG BASETABLET / ORALABRLD1997-11-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020839-002PLAVIXEQ 300MG BASETABLET / ORALABRLD2007-09-20bb7c543d1eb4…

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 06:07:402026-07N020839-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020839-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020839-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020839-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020839-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020839-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020839-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020839-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020839-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020839-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020839-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020839-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020839-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020839-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020839-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020839-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020839-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020839-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020839-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020839-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020839-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020839-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020839-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020839-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020839-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020839-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020839-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020839-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020839-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020839-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020839-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020839-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020839-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020839-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020839-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020839-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020839-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020839-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020839-002AB1bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020839-00164292102019-06-10Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-00165040302019-06-10Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-0016429210*PED2019-12-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-0016504030*PED2019-12-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-00264292102019-06-10Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-00265040302019-06-10Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-0026429210*PED2019-12-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020839-0026504030*PED2019-12-10Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020839-00164292102019-06-10Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-00165040302019-06-10Drug substance3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-0016429210*PED2019-12-10Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-0016504030*PED2019-12-10Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-00264292102019-06-10Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-00265040302019-06-10Drug substance3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-0026429210*PED2019-12-10Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020839-0026504030*PED2019-12-10Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020839-00164292102019-06-10Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-00165040302019-06-10Drug substanceb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-0016429210*PED2019-12-10Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-0016504030*PED2019-12-10Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-00264292102019-06-10Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-00265040302019-06-10Drug substanceb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-0026429210*PED2019-12-10Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020839-0026504030*PED2019-12-10Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020839-00164292102019-06-10Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-00165040302019-06-10Drug substanceea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-0016429210*PED2019-12-10Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-0016504030*PED2019-12-10Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-00264292102019-06-10Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-00265040302019-06-10Drug substanceea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-0026429210*PED2019-12-10Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020839-0026504030*PED2019-12-10Pediatric extensionea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Plavix
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213169Internal RxNorm lookup
309362Internal RxNorm lookup
749196Internal RxNorm lookup
749198Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de8b0b67-eb25-4684-83b5-7ad785314227Available 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
0024-1171-90Plavix90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-1171-90EA - Each0024-1171f374a7e3-e0d3-4adf-b55d-cf3282daa23912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-1171PLAVIX (CLOPIDOGREL) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4Current NDC, Legacy NDC, 1 package rows20240822_de8b0b67-eb25-4684-83b5-7ad785314227.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlavixCLOPIDOGRELSanofi-Aventis U.S. LLCde8b0b67-eb25-4684-83b5-7ad7853142272025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020839
application number: NDA020839
ndc (product): 0024-1171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749196clopidogrel 300 MG Oral TabletPSNde8b0b67-eb25-4684-83b5-7ad7853142275
309362clopidogrel 75 MG Oral TabletPSNde8b0b67-eb25-4684-83b5-7ad7853142275
749198Plavix 300 MG Oral TabletPSNde8b0b67-eb25-4684-83b5-7ad7853142275
213169Plavix 75 MG Oral TabletPSNde8b0b67-eb25-4684-83b5-7ad7853142275
749198clopidogrel 300 MG Oral Tablet [Plavix]SBDde8b0b67-eb25-4684-83b5-7ad7853142275
213169clopidogrel 75 MG Oral Tablet [Plavix]SBDde8b0b67-eb25-4684-83b5-7ad7853142275
749196clopidogrel 300 MG Oral TabletSCDde8b0b67-eb25-4684-83b5-7ad7853142275
309362clopidogrel 75 MG Oral TabletSCDde8b0b67-eb25-4684-83b5-7ad7853142275
749196clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275
309362clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275
749198Plavix 300 MG (clopidogrel bisulfate 391.5 MG) Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275
749198Plavix 300 MG Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275
213169Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275
213169Plavix 75 MG Oral TabletSYde8b0b67-eb25-4684-83b5-7ad7853142275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-1171-900002411719090 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90) 2020-07-130000-00-00NoNoCurrent