Clopidogrel

Product NDC: 69367-200
11-digit product format: 693670200
Labeler code: 69367
Product ID: 69367-200_e988b70b-0906-4e72-b032-97033e37aa0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel Bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA204165
Marketing category: ANDA
Marketing start: 2023-05-15
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204165-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-09-15
A204165-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2014-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204165-001	AB
A204165-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A204165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204165-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204165-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204165-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204165-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204165-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204165-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204165-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204165-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204165-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204165-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204165-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204165-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204165-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204165-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204165-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204165-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204165-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204165-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204165-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204165-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204165-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204165-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204165-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204165-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204165-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204165-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204165-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204165-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204165-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204165-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204165-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204165-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204165-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204165-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204165-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204165-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204165-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204165-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204165-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309362	Internal RxNorm lookup
749196	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
bb3b5e96-e629-4db5-8ad5-40c17c6dae18	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	Strength	SPL version
69367-200-05	Clopidogrel	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-200-05	EA - Each	69367-200	5ebef090-44c5-404a-b331-9bebd940a0e1	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-200	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]	7	Current NDC, 1 package rows	20230910_bb3b5e96-e629-4db5-8ad5-40c17c6dae18.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL BISULFATE	Westminster Pharmaceuticals, LLC	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	2026-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165 ndc (product): 69367-200
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	2969deac-274b-4042-9c90-9522e62a979d	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Preferred Pharmaceuticals, Inc.	e51d4bcc-01df-409d-9179-45e6536ac25b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NCS HealthCare of KY, LLC dba Vangard Labs	8406b8e3-e203-402f-8858-2748119e2351	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL BISULFATE	AvPAK	94a5cdc4-e063-1d46-e053-2995a90a7e15	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	a7bf847d-43e9-166e-e053-2995a90a239e	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL BISULFATE	Proficient Rx LP	330702d9-842c-416d-9b11-b4a9b707e9b2	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	539265a6-e356-42cd-bde9-ac704f108c74	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	RADHA PHARMACEUTICALS, INC.	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	7c4b3bc3-8f3b-4232-835d-e37d93b92c3e	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	ScieGen Pharmaceuticals Inc	d03cfc18-c9e4-41f8-b54d-6a7564c32afb	2023-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Proficient Rx LP	4842be24-3919-48ae-9302-eb9d3d921224	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL	Vensun Pharmaceuticals, Inc.	86ee71f2-850e-4c8e-87f3-c7a618d59d95	2019-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165

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
749196	clopidogrel 300 MG Oral Tablet	PSN	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7
309362	clopidogrel 75 MG Oral Tablet	PSN	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7
749196	clopidogrel 300 MG Oral Tablet	SCD	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7
309362	clopidogrel 75 MG Oral Tablet	SCD	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7
749196	clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet	SY	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69367-200-05	69367020005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-200-05)	2023-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	Westminster Pharmaceuticals, LLC	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	8
Clopidogrel	REMEDYREPACK INC.	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	2