Home NDC 69844-036 CLOPIDOGREL BISULFATE
Product NDC 69844-036
11-digit product format 698440036
Labeler code 69844
Product ID 69844-036_ef39ff78-4d7c-1d27-e053-2995a90a1075
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOPIDOGREL BISULFATE
Dosage form TABLET
Route ORAL
Labeler Graviti Pharmaceuticals Private Limited
Application ANDA204359
Marketing category ANDA
Marketing start 2020-04-06
Marketing end 0000-00-00
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 2023-12-31
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-036-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-036-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-036-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-036-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-036-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-036-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-036-03 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-036-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-036-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-036-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-036-03 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-036-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-036-04 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-036-01 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-036-03 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-036-02 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204359-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204359-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204359-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2017-02-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69844-036-01 2022-12-07 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-02 2022-12-07 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-03 2022-12-07 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-04 2022-12-07 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-01 2022-01-28 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-02 2022-01-28 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-03 2022-01-28 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997 69844-036-04 2022-01-28 These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69844-036-01 69844003601 30 TABLET in 1 BOTTLE (69844-036-01) 30 tablet 2020-04-06 0000-00-00 No No Current 69844-036-02 69844003602 90 TABLET in 1 BOTTLE (69844-036-02) 90 tablet 2020-04-06 0000-00-00 No No Current 69844-036-03 69844003603 500 TABLET in 1 BOTTLE (69844-036-03) 500 tablet 2020-04-06 0000-00-00 No No Current 69844-036-04 69844003604 1000 TABLET in 1 BOTTLE (69844-036-04) 1000 tablet 2020-04-06 0000-00-00 No No Current