Clopidogrel

Product NDC: 51407-032
Requested package NDC: 51407-032-30
11-digit product format: 514070032
Labeler code: 51407
Product ID: 51407-032_43fba049-b691-b443-e063-6394a90a4000
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA076274
Marketing category: ANDA
Marketing start: 2012-05-17
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: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51407-032	51407-032-30	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
51407-032-10	Clopidogrel	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	10
51407-032-30	Clopidogrel	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
51407-032-90	Clopidogrel	90 in 1 BOTTLE	TABLET, FILM COATED	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-032-10	EA - Each	51407-032	61807024-1343-44b3-84ff-c1cd85a6a43a	1	2018-04-19
51407-032-30	EA - Each	51407-032	6db2ac32-504d-4a9e-b9c5-3ded9e1e1d6c	1	2018-04-19
51407-032-90	EA - Each	51407-032	432d684c-bc2a-459c-8daf-1f07c34c29ee	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-032	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241213_84bb2c2c-4c41-4aa4-a52b-3d6eed794ada.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	d49362ae-f78a-47d8-ac14-8262d621fcaa	1
309362	clopidogrel 75 MG Oral Tablet	SCD	d49362ae-f78a-47d8-ac14-8262d621fcaa	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	d49362ae-f78a-47d8-ac14-8262d621fcaa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-032-30	51407003230	30 TABLET, FILM COATED in 1 BOTTLE (51407-032-30)	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	Golden State Medical Supply, Inc.	2025-11-19	HUMAN PRESCRIPTION DRUG LABEL	10
Clopidogrel	Aphena Pharma Solutions - Tennessee, LLC	2021-03-18	HUMAN PRESCRIPTION DRUG LABEL	1