Home NDC 63187-362 Clopidogrel
Product NDC 63187-362
11-digit product format 631870362
Labeler code 63187
Product ID 63187-362_34f7e985-f275-4c4b-ab35-ffa37e49052b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA076999
Marketing category ANDA
Marketing start 2012-05-17
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 A076999-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076999-001 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 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076999-001 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 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076999-001 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 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076999-001 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 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076999-001 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 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076999-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 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 63187-362-30 Clopidogrel 30 in 1 BOTTLE TABLET, FILM COATED 30 3 63187-362-60 Clopidogrel 60 in 1 BOTTLE TABLET, FILM COATED 60 3 63187-362-90 Clopidogrel 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-362 CLOPIDOGREL TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 3 package rows 20210115_25ed3120-7960-4e87-8422-de5c2026062c.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clopidogrel CLOPIDOGREL NuCare Pharmaceuticals,Inc. 5cdca9bd-7042-142a-e053-2991aa0a9ca6 2025-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076999 application number: ANDA076999 Clopidogrel CLOPIDOGREL Proficient Rx LP 25ed3120-7960-4e87-8422-de5c2026062c 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076999 application number: ANDA076999 ndc (product): 63187-362 Clopidogrel CLOPIDOGREL Teva Pharmaceuticals USA, Inc. bc747f6d-f52c-4dcb-bda5-2d0a9f954147 2019-08-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076999 application number: ANDA076999
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-362-30 63187036230 30 TABLET, FILM COATED in 1 BOTTLE (63187-362-30) 2016-08-01 0000-00-00 No No Current 63187-362-60 63187036260 60 TABLET, FILM COATED in 1 BOTTLE (63187-362-60) 2016-08-01 0000-00-00 No No Current 63187-362-90 63187036290 90 TABLET, FILM COATED in 1 BOTTLE (63187-362-90) 2016-08-01 0000-00-00 No No Current