Home NDC 52605-082 clopidogrel
Product NDC 52605-082
11-digit product format 526050082
Labeler code 52605
Product ID 52605-082_9e3256b5-2032-4615-967d-449d49b09921
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clopidogrel
Dosage form TABLET
Route ORAL
Labeler POLYGEN PHARMACEUTICALS INC.
Application ANDA213351
Marketing category ANDA
Marketing start 2021-03-01
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 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 A213351-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 A213351-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17
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 · 76 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 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base clopidogrel
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309362 Internal RxNorm lookup 749196 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 52605-082-10 clopidogrel 1000 in 1 BOTTLE, DISPENSING TABLET 1000 5 52605-082-13 clopidogrel 30 in 1 BOTTLE TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52605-082 CLOPIDOGREL TABLET CLOPIDOGREL TABLET [POLYGEN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20220730_56b5d12b-b3fe-4de9-a5ef-80377c72d843.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 Units Marketing start Marketing end Sample Exclude flag Status 52605-082-10 52605008210 1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10) 1000 tablet 2021-03-01 0000-00-00 No No Current 52605-082-13 52605008213 30 TABLET in 1 BOTTLE (52605-082-13) 30 tablet 2021-03-01 0000-00-00 No No Current