Clopidogrel

Product NDC: 0615-8014
11-digit product format: 006158014
Labeler code: 0615
Product ID: 0615-8014_b5b91d67-b29c-4568-a76b-079a429352d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA076274
Marketing category: ANDA
Marketing start: 2012-05-17
Marketing end: 2026-07-31
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
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0615-8014		D	Discontinued by firm	2026-08-17
excluded package	package	0615-8014	0615-8014-05	D	Discontinued by firm	2026-08-17
excluded package	package	0615-8014	0615-8014-07	D	Discontinued by firm	2026-08-17
excluded package	package	0615-8014	0615-8014-30	D	Discontinued by firm	2026-08-17
excluded package	package	0615-8014	0615-8014-39	D	Discontinued by firm	2026-08-17

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0615-8014-05	Clopidogrel	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	26
0615-8014-07	Clopidogrel	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	26
0615-8014-30	Clopidogrel	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	26
0615-8014-30	Clopidogrel	6 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	6	26
0615-8014-39	Clopidogrel	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8014	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	25	Current NDC, Legacy NDC, 5 package rows	20240919_d14849e1-58f8-44de-9a9d-a1bb23d1f294.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
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
309362	clopidogrel 75 MG Oral Tablet	PSN	d14849e1-58f8-44de-9a9d-a1bb23d1f294	26
309362	clopidogrel 75 MG Oral Tablet	SCD	d14849e1-58f8-44de-9a9d-a1bb23d1f294	26
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	d14849e1-58f8-44de-9a9d-a1bb23d1f294	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8014-05	00615801405	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-05)		2016-05-04	2026-07-31	No	No	Current
0615-8014-07	00615801407	7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-07)		2024-08-03	2026-07-31	No	No	Historical
0615-8014-30	00615801430	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8014-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK	6 blister pack	2016-05-19	2026-07-31	No	No	Current
0615-8014-39	00615801439	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8014-39)		2016-05-04	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-17	HUMAN PRESCRIPTION DRUG LABEL	26