Clopidogrel Bisulfate

Product NDC: 50090-1300
11-digit product format: 500901300
Labeler code: 50090
Product ID: 50090-1300_6e347ab6-96ca-484a-87f4-2cbfb4fc16e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel Bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090494
Marketing category: ANDA
Marketing start: 2012-05-18
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: 2022-12-31
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	50090-1300		I	Inactivated by FDA	2026-08-17
excluded package	package	50090-1300	50090-1300-0	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-1300	50090-1300-1	I	Inactivated by FDA	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 · 45 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	50090-1300-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1300-1	`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	50090-1300-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1300-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1300-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1300-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1300-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1300-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1300-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1300-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1300-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1300-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1300-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1300-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1300-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1300-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1300-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1300-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1300-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1300-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1300-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1300-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1300-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1300-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1300-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1300-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1300-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1300-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1300-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1300-1	`1332a3947898…`	`d4bfe170f9cd…`

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
A090494-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL			2012-05-17

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	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090494-001	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	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090494-001	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	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090494-001	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	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090494-001	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	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090494-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090494-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090494-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090494-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090494-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090494-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090494-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090494-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090494-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090494-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090494-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090494-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090494-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090494-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090494-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090494-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090494-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090494-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090494-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090494-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090494-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090494-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39fa80eb-1490-ce82-3d3a-820ae7c37b85	Product name	5	20250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1300-0	2023-01-30	C162847	48780-1	f386c649-d29c-0266-e053-dadaa90a7c1a	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
50090-1300-1	2023-01-30	C162847	48780-1	f386c649-d29c-0266-e053-dadaa90a7c1a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1300-0	Clopidogrel Bisulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30		7
50090-1300-1	Clopidogrel Bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1300	CLOPIDOGREL BISULFATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 2 package rows	20210415_7e19b760-8324-4f05-b49b-f6be84aaa43f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel Bisulfate	CLOPIDOGREL BISULFATE	Sun Pharmaceutical Industries, Inc.	d37db064-3a5a-4a0c-a60b-b4b417fe742a	2022-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090494 application number: ANDA090494

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	7e19b760-8324-4f05-b49b-f6be84aaa43f	7
309362	clopidogrel 75 MG Oral Tablet	SCD	7e19b760-8324-4f05-b49b-f6be84aaa43f	7
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	7e19b760-8324-4f05-b49b-f6be84aaa43f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1300-0	50090130000	30 TABLET, FILM COATED in 1 BOTTLE (50090-1300-0)	2014-11-28	0000-00-00	No	No	Current
50090-1300-1	50090130001	90 TABLET, FILM COATED in 1 BOTTLE (50090-1300-1)	2014-11-01	0000-00-00	No	No	Current