Clopidogrel

Product NDC: 60505-3992
11-digit product format: 605053992
Labeler code: 60505
Product ID: 60505-3992_2f390e08-7999-65b9-0efa-12c0768eec91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA076274
Marketing category: ANDA
Marketing start: 2012-05-17
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-3992		D	Discontinued by firm		2026-08-17
excluded package	package	60505-3992	60505-3992-3	D	Discontinued by firm		2026-08-17

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 2 · 64 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-3992-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	60505-3992-8	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`

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
A076274-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17
A076274-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076274-001	AB
A076274-002	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 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	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076274-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076274-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076274-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076274-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076274-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076274-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076274-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076274-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076274-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076274-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076274-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076274-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076274-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076274-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076274-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076274-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076274-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076274-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39fa80eb-1490-ce82-3d3a-820ae7c37b85	Product name	5	20250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60505-3992-3	2021-05-17	C162847	48780-1	ba0f9c33-5108-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS . CLOPIDOGREL tablets for oral use Initial U.S. Approval: 1997
60505-3992-3	2021-01-29	C162847	48780-1	ba0f9c33-5108-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS . CLOPIDOGREL tablets for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-3992-3	Clopidogrel	30 in 1 BOTTLE	TABLET, FILM COATED	30		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3992-3	EA - Each	60505-3992	022de133-fdd3-47c9-b393-0445a60a58ae	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOPIDOGREL BISULFATE	ACTIVE INGREDIENT	08I79HTP27	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
CLOPIDOGREL	ACTIVE MOIETY	A74586SNO7	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
METHYLCELLULOSE (15 CPS)	INACTIVE INGREDIENT	NPU9M2E6L8	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3992	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [APOTEX CORP.]	25	Legacy NDC, 1 package rows	20240925_edae8df1-caf9-ff72-1304-5ae8b355f8e7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL BISULFATE	Cardinal Health 107, LLC	c03a895c-2d74-4d7f-891f-b752ce409b68	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274
Clopidogrel	CLOPIDOGREL BISULFATE	Apotex Corp.	edae8df1-caf9-ff72-1304-5ae8b355f8e7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 60505-3992
Clopidogrel	CLOPIDOGREL BISULFATE	Major Pharmaceuticals	4cd07a3c-9673-4aa0-b76a-d79df2399ee1	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274
Clopidogrel	CLOPIDOGREL BISULFATE	American Health Packaging	65ea4dc6-acb2-4609-9a4c-4866ef0ccb11	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274
Clopidogrel	CLOPIDOGREL BISULFATE	Aphena Pharma Solutions - Tennessee, LLC	d49362ae-f78a-47d8-ac14-8262d621fcaa	2021-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749196	clopidogrel 300 MG Oral Tablet	PSN	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26
309362	clopidogrel 75 MG Oral Tablet	PSN	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26
749196	clopidogrel 300 MG Oral Tablet	SCD	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26
309362	clopidogrel 75 MG Oral Tablet	SCD	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26
749196	clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet	SY	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	edae8df1-caf9-ff72-1304-5ae8b355f8e7	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3992-3	60505399203	30 TABLET, FILM COATED in 1 BOTTLE (60505-3992-3)	2012-05-17	0000-00-00	No	No	Current