Clopidogrel

Product NDC: 71335-0080
11-digit product format: 713350080
Labeler code: 71335
Product ID: 71335-0080_1de06f75-f138-4f1d-b71e-ad82b549d41b
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
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOPIDOGREL BISULFATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08I79HTP27	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309362	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8f98886-4771-4be3-8b57-edfbbc1b4661	Available on FDA.report

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
71335-0080-1	Clopidogrel	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
71335-0080-2	Clopidogrel	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
71335-0080-3	Clopidogrel	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
71335-0080-4	Clopidogrel	20 in 1 BOTTLE	TABLET, FILM COATED	20	8
71335-0080-5	Clopidogrel	10 in 1 BOTTLE	TABLET, FILM COATED	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0080-1	EA - Each	71335-0080	49fc14f7-f642-47a8-b2d1-b52876797605	1	2018-03-08
71335-0080-2	EA - Each	71335-0080	9d481f76-ae0a-4432-970a-3881f0d53a8e	1	2018-03-08
71335-0080-3	EA - Each	71335-0080	1a27a737-d912-47c8-b2e1-048f413d2166	1	2018-03-08
71335-0080-4	EA - Each	71335-0080	06baafdc-5132-4926-908b-1d90f664c995	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0080	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 5 package rows	20240601_e8f98886-4771-4be3-8b57-edfbbc1b4661.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 · 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 ndc (product): 71335-0080
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309362	clopidogrel 75 MG Oral Tablet	PSN	e8f98886-4771-4be3-8b57-edfbbc1b4661	8
309362	clopidogrel 75 MG Oral Tablet	SCD	e8f98886-4771-4be3-8b57-edfbbc1b4661	8
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	e8f98886-4771-4be3-8b57-edfbbc1b4661	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0080-1	71335008001	90 TABLET, FILM COATED in 1 BOTTLE (71335-0080-1)	2023-04-21	0000-00-00	No	No	Current
71335-0080-2	71335008002	30 TABLET, FILM COATED in 1 BOTTLE (71335-0080-2)	2023-05-02	0000-00-00	No	No	Current
71335-0080-3	71335008003	60 TABLET, FILM COATED in 1 BOTTLE (71335-0080-3)	2024-05-29	0000-00-00	No	No	Current
71335-0080-4	71335008004	20 TABLET, FILM COATED in 1 BOTTLE (71335-0080-4)	2024-05-29	0000-00-00	No	No	Current
71335-0080-5	71335008005	10 TABLET, FILM COATED in 1 BOTTLE (71335-0080-5)	2024-05-29	0000-00-00	No	No	Current