Home NDC 66116-494 Clopidogrel
Product NDC 66116-494
11-digit product format 661160494
Labeler code 66116
Product ID 66116-494_89033966-72f2-44b3-8335-3d12e82f27fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MedVantx, Inc.
Application ANDA076999
Marketing category ANDA
Marketing start 2012-05-17
Marketing end 0000-00-00
Substance CLOPIDOGREL BISULFATE
Active strength 75 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66116-494-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66116-494-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66116-494-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66116-494-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66116-494-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66116-494-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66116-494-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66116-494-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66116-494-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66116-494-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66116-494-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66116-494-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66116-494-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66116-494-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66116-494-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66116-494-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66116-494-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66116-494-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66116-494-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66116-494-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66116-494-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66116-494-30 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66116-494-30 Clopidogrel 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66116-494 CLOPIDOGREL TABLET, FILM COATED [MEDVANTX, INC.] 1 Legacy NDC, 1 package rows 20130816_89033966-72f2-44b3-8335-3d12e82f27fe.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 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 Status 66116-494-30 66116049430 30 in 1 BOTTLE Historical