Clopidogrel

Product NDC: 63629-6857
Requested package NDC: 63629-6857-1
11-digit product format: 636296857
Labeler code: 63629
Product ID: 63629-6857_c5a988b9-b074-473c-91da-f4e68315f872
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel Bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090540
Marketing category: ANDA
Marketing start: 2012-05-17
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-6857	63629-6857-1	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 1 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090540-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090540-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090540-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A090540-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090540-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090540-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090540-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090540-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090540-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090540-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090540-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090540-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090540-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090540-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090540-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090540-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090540-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090540-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090540-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090540-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090540-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090540-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090540-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090540-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090540-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090540-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090540-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090540-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090540-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090540-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090540-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090540-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090540-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090540-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090540-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090540-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090540-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090540-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090540-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090540-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090540-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090540-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090540-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6857-1	2020-10-16	C162847	48780-1	9d75b9d0-29ad-f424-e053-dadaa90a57ce	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
63629-6857-1	2020-01-31	C162847	48780-1	9d75b9d0-29ad-f424-e053-dadaa90a57ce	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

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	3e2539c1-a6ad-4d60-944c-c2e7aa70ce45	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	Legacy Pharmaceutical Packaging, LLC	53de10a5-dbd0-413d-90e5-00a1920ec391	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	553b4938-4462-4aeb-e054-00144ff88e88	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	55530ff3-5ce4-120f-e054-00144ff8d46c	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	PD-Rx Pharmaceuticals, Inc.	20247bf8-30ec-4807-95c1-8ec7587368ae	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	A-S Medication Solutions	e19174f4-ec3c-4cd6-ad7d-d1e882f9d7b4	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	e8f98886-4771-4be3-8b57-edfbbc1b4661	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	Aurobindo Pharma Limited	0078fb3d-3595-4ae1-a059-1d5e81c879cf	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	A-S Medication Solutions	b6e6a9b8-bf91-4e7f-b872-880afb558426	2023-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540
Clopidogrel	CLOPIDOGREL BISULFATE	Proficient Rx LP	ec296eed-81d0-4c1e-bff4-431851899157	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090540 application number: ANDA090540

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6857-1	63629685701	30 TABLET, FILM COATED in 1 BOTTLE (63629-6857-1)	2015-11-25	0000-00-00	No	No	Current