Home NDC 55289-911 Plavix
Product NDC 55289-911
11-digit product format 552890911
Labeler code 55289
Product ID 55289-911_dac16e9c-9020-32c9-e053-2995a90a4dee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020839
Marketing category NDA
Marketing start 1997-11-17
Marketing end 2022-07-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020839-001 PLAVIX CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 N020839-002 PLAVIX CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD, RS 2007-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020839-001 6429210 2019-06-10 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6504030 2019-06-10 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6429210*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6504030*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6429210 2019-06-10 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6504030 2019-06-10 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6429210*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6504030*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020839-001 6429210 2019-06-10 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6504030 2019-06-10 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6429210*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6504030*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6429210 2019-06-10 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6504030 2019-06-10 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6429210*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6504030*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020839-001 6429210 2019-06-10 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6504030 2019-06-10 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6429210*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6504030*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6429210 2019-06-10 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6504030 2019-06-10 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6429210*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6504030*PED 2019-12-10 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020839-001 6429210 2019-06-10 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6504030 2019-06-10 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6429210*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6504030*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6429210 2019-06-10 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6504030 2019-06-10 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6429210*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6504030*PED 2019-12-10 Pediatric extension ea99ee380514…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded clopidogrel bisulfate ACTIVE INGREDIENT 08I79HTP27 PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 clopidogrel ACTIVE MOIETY A74586SNO7 PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 castor oil INACTIVE INGREDIENT D5340Y2I9G PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 mannitol INACTIVE INGREDIENT 3OWL53L36A PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 triacetin INACTIVE INGREDIENT XHX3C3X673 PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Plavix CLOPIDOGREL Sanofi-Aventis U.S. LLC de8b0b67-eb25-4684-83b5-7ad785314227 2025-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020839 application number: NDA020839
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-911-15 55289091115 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-911-15) 2011-05-10 0000-00-00 No No Current 55289-911-30 55289091130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-911-30) 2011-05-10 0000-00-00 No No Current