Home NDC 65162-414 Clopidogrel
Product NDC 65162-414
11-digit product format 651620414
Labeler code 65162
Product ID 65162-414_360ed8dd-4f92-46fc-b31b-abe0d75e9bb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203751
Marketing category ANDA
Marketing start 2013-09-30
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203751-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203751-001 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 · 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 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203751-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2014-04-11 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 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 65162-414-03 Clopidogrel 30 in 1 BOTTLE TABLET 30 24 65162-414-09 Clopidogrel 90 in 1 BOTTLE TABLET 90 24 65162-414-11 Clopidogrel 1000 in 1 BOTTLE TABLET 1000 24 65162-414-50 Clopidogrel 500 in 1 BOTTLE TABLET 500 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-414 CLOPIDOGREL TABLET [AMNEAL PHARMACEUTICALS LLC] 23 Current NDC, Legacy NDC, 4 package rows 20241027_0d010775-1160-4b2e-a928-563a02edd191.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 65162-414-03 65162041403 30 TABLET in 1 BOTTLE (65162-414-03) 30 tablet 2013-09-30 0000-00-00 No No Current 65162-414-09 65162041409 90 TABLET in 1 BOTTLE (65162-414-09) 90 tablet 2013-09-30 0000-00-00 No No Current 65162-414-11 65162041411 1000 TABLET in 1 BOTTLE (65162-414-11) 1000 tablet 2013-09-30 0000-00-00 No No Current 65162-414-50 65162041450 500 TABLET in 1 BOTTLE (65162-414-50) 500 tablet 2013-09-30 0000-00-00 No No Current