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
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 78 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 2026-09-14 22:38:34 2026-08 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Legacy NDC, 2 package rows 20220730_56b5d12b-b3fe-4de9-a5ef-80377c72d843.zip
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