Home NDC 53808-0806 Clopidogrel Bisulfate
Product NDC 53808-0806
11-digit product format 538080806
Labeler code 53808
Product ID 53808-0806_28c48b4c-4ef3-4047-b3c3-3ef51ff98532
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel Bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA090494
Marketing category ANDA
Marketing start 2013-01-01
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 E
Listing certified through 2018-12-31
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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0806-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0806-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0806-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0806-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0806-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0806-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0806-2 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0806-2 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0806-2 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0806-2 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0806-2 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0806-2 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0806-2 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0806-2 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0806-2 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 53808-0806-2 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 53808-0806-2 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 53808-0806-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0806-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0806-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0806-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0806-2 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090494-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17
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 · 42 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 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 e64feba35796…
Observed Orange Book normalized TE history# 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 53808-0806-2 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 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 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 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O 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 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 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 53808-0806 CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140404_97bb6455-dcfa-4fac-a4a1-8a2d56516f38.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0806-2 53808080602 60 in 1 BLISTER PACK Historical