Clopidogrel

Product NDC: 70518-0400
11-digit product format: 705180400
Labeler code: 70518
Product ID: 70518-0400_e7a2c2cc-f959-6e33-e053-2995a90a928e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202928
Marketing category: ANDA
Marketing start: 2017-04-05
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0400		D	Discontinued by firm	2026-08-17
excluded package	package	70518-0400	70518-0400-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-0400	70518-0400-1	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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0400-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0400-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0400-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0400-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0400-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0400-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0400-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0400-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0400-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0400-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0400-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0400-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0400-1	`367a005e9d99…`	`383a685ebd0f…`

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
A202928-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202928-001	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	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`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	A202928-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL	Redpharm Drug	55731d95-0c99-ff61-e063-6394a90a1ab5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	NorthStar RxLLC	d176de1d-b1b3-4aa9-b783-d53f65a79e50	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	02f0eaf8-0fc2-425d-8259-cef00156e25d	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3aef6fd4-7160-4678-9362-ca76174bfd0e	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3c8c68ca-aa48-43f0-977d-2608e1666be4	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	Bryant Ranch Prepack	85df051d-0fa9-41b3-8862-9d6ca851a9cc	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	Macleods Pharmaceuticals Limited	063cd1eb-98fd-422e-8145-bba04c497efe	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE
A74586SNO7	CLOPIDOGREL	113665-84-2	Clopidogrel

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0400-0	70518040000	90 TABLET in 1 BOTTLE, PLASTIC (70518-0400-0)	90 tablet	2017-04-05	0000-00-00	No	No	Current
70518-0400-1	70518040001	30 TABLET in 1 BLISTER PACK (70518-0400-1)	30 tablet	2017-04-14	0000-00-00	No	No	Current