Home NDC 16729-218-15 Clopidogrel
Product NDC 16729-218
Requested package NDC 16729-218-15
11-digit product format 167290218
Labeler code 16729
Product ID 16729-218_d481c0f7-ad3d-c647-e053-2a95a90ac06c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clopidogrel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA202925
Marketing category ANDA
Marketing start 2013-11-21
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 No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A202925-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 A202925-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27
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 3 · 84 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 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 6 CLOPIDOGREL BISULFATE ACTIVE INGREDIENT 08I79HTP27 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CLOPIDOGREL ACTIVE MOIETY A74586SNO7 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLOPIDOGREL (CLOPIDOGREL BISULPHATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 16729-218-15 16729021815 90 TABLET, FILM COATED in 1 BOTTLE (16729-218-15) 2013-11-21 0000-00-00 No No Current