Home NDC 82009-182 Clopidogrel bisulfate
Product NDC 82009-182
11-digit product format 820090182
Labeler code 82009
Product ID 82009-182_b225308c-50b5-6c91-fc03-1506c1b2dedc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel bisulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quallent Pharmaceuticals Health LLC
Application ANDA091023
Marketing category ANDA
Marketing start 2025-09-05
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82009-182 82009-182-90 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A091023-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 A091023-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05
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 2 · 55 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 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091023-002 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2024-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091023-001 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2012-05-17 ea99ee380514…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 55 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clopidogrel bisulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOPIDOGREL BISULFATE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 08I79HTP27 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309362 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82009-182-05 Clopidogrel bisulfate 500 in 1 BOTTLE TABLET, FILM COATED 500 2 82009-182-90 Clopidogrel bisulfate 90 in 1 BOTTLE TABLET, FILM COATED 90 2
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clopidogrel bisulfate CLOPIDOGREL BISULFATE REMEDYREPACK INC. e5ee3807-5c9d-4b65-b188-4159a0fb1c85 2026-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Quallent Pharmaceuticals Health LLC d072b6ea-2bb4-8965-918e-23f9080efcb0 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 ndc (product): 82009-182 Clopidogrel bisulfate CLOPIDOGREL BISULFATE McKesson Corporation dba SKY Packaging 823c5dd0-f4e6-9b45-54de-a609caa8fa90 2025-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Dr.Reddy's Laboratories Inc 45caaa95-8470-b459-5f82-8156072d1878 2025-03-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023 Clopidogrel bisulfate CLOPIDOGREL BISULFATE Dr.Reddy's Laboratories Limited 4da4da53-91ae-4d4f-145f-255c5db443a5 2023-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091023 application number: ANDA091023
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82009-182-05 82009018205 500 TABLET, FILM COATED in 1 BOTTLE (82009-182-05) 2025-09-05 No No Current 82009-182-90 82009018290 90 in 1 BOTTLE Historical