Clopidogrel

Product NDC: 55154-2149
11-digit product format: 551542149
Labeler code: 55154
Product ID: 55154-2149_f2c8b1d7-dfbb-488c-b554-3b2d685fd6b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel Bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA076274
Marketing category: ANDA
Marketing start: 2025-10-10
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: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c03a895c-2d74-4d7f-891f-b752ce409b68	Available on FDA.report

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	Strength	SPL version
55154-2149-0	Clopidogrel	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
55154-2149-0	Clopidogrel	10 in 1 BAG	TABLET, FILM COATED	10		3

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 ndc (product): 55154-2149
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	c03a895c-2d74-4d7f-891f-b752ce409b68	3
309362	clopidogrel 75 MG Oral Tablet	SCD	c03a895c-2d74-4d7f-891f-b752ce409b68	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	c03a895c-2d74-4d7f-891f-b752ce409b68	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2149-0	55154214900	10 BLISTER PACK in 1 BAG (55154-2149-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-10-10	No	No	Current