Home NDC 53808-1002 Clopidogrel bisulfate
Product NDC 53808-1002
11-digit product format 538081002
Labeler code 53808
Product ID 53808-1002_7d66ef28-a10c-4c41-b228-ed1d6c55dfb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA076273
Marketing category ANDA
Marketing start 2014-11-01
Marketing end 0000-00-00
Substance CLOPIDOGREL BISULFATE
Active strength 75 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A076273-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076273-001 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 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076273-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2008-01-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-1002-1 Clopidogrel bisulfate 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1 53808-1002-2 Clopidogrel bisulfate 60 in 1 BLISTER PACK TABLET, FILM COATED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-1002 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 2 package rows 20150107_8d0ed864-bbb3-4d6b-892d-64754eec1494.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-1002-1 53808100201 30 in 1 BLISTER PACK Historical 53808-1002-2 53808100202 60 in 1 BLISTER PACK Historical