Clopidogrel Bisulfate

Product NDC: 0904-6294
11-digit product format: 009046294
Labeler code: 0904
Product ID: 0904-6294_c55b83a2-a7e7-407b-ae9d-fdfc2f86e384
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel Bisulfate
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA090844
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-6294		D	Discontinued by firm		2026-08-17
excluded package	package	0904-6294	0904-6294-61	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090844-001	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
A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090844-001	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	A090844-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090844-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090844-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090844-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090844-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090844-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090844-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090844-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090844-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090844-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090844-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090844-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090844-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090844-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090844-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090844-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090844-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090844-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090844-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090844-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090844-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090844-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090844-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090844-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090844-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090844-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090844-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090844-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090844-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090844-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090844-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090844-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090844-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090844-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090844-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090844-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090844-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090844-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090844-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090844-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6294-61	EA - Each	0904-6294	83499f4d-816c-4aef-a686-301bdc11a0ad	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOPIDOGREL BISULFATE	ACTIVE INGREDIENT	08I79HTP27	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
CLOPIDOGREL	ACTIVE MOIETY	A74586SNO7	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOPIDOGREL BISULFATE TABLET [MAJOR PHARMACEUTICALS]	5
CLOPIDOGREL BISULFATE	ACTIVE INGREDIENT	08I79HTP27	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
CLOPIDOGREL	ACTIVE MOIETY	A74586SNO7	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOPIDOGREL BISULFATE TABLET [CARDINAL HEALTH]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6294	CLOPIDOGREL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	13	Legacy NDC	20250418_c3248d43-3dd6-4ca9-afca-528c7abe0fce.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel Bisulfate	CLOPIDOGREL BISULFATE	PD-Rx Pharmaceuticals, Inc.	03bec9ad-cd22-44d3-9b82-2796157de1d1	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090844 application number: ANDA090844
Clopidogrel	CLOPIDOGREL	Torrent Pharmaceuticals Limited	ae07b785-b522-41c6-b27c-24c4d5cd814d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090844 application number: ANDA090844

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6294-61	00904629461	100 BLISTER PACK in 1 CARTON (0904-6294-61) > 1 TABLET in 1 BLISTER PACK	100 blister pack	2012-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	Cardinal Health 107, LLC	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	14
Clopidogrel	Major Pharmaceuticals	2025-04-14	HUMAN PRESCRIPTION DRUG LABEL	13