Clopidogrel bisulfate

Product NDC: 63187-639
11-digit product format: 631870639
Labeler code: 63187
Product ID: 63187-639_39837b40-4b4c-4030-8a8a-7176c9f543e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA204165
Marketing category: ANDA
Marketing start: 2014-04-01
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 · 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 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel bisulfate
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
4842be24-3919-48ae-9302-eb9d3d921224	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-639-30	Clopidogrel bisulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
63187-639-60	Clopidogrel bisulfate	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
63187-639-90	Clopidogrel bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-639	CLOPIDOGREL BISULFATE TABLET, FILM COATED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20191126_4842be24-3919-48ae-9302-eb9d3d921224.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 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	REMEDYREPACK INC.	2969deac-274b-4042-9c90-9522e62a979d	2025-09-25	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	CLOPIDOGREL BISULFATE	Westminster Pharmaceuticals, LLC	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	2023-09-08	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 ndc (product): 63187-639
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
309362	clopidogrel 75 MG Oral Tablet	PSN	4842be24-3919-48ae-9302-eb9d3d921224	3
309362	clopidogrel 75 MG Oral Tablet	SCD	4842be24-3919-48ae-9302-eb9d3d921224	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	4842be24-3919-48ae-9302-eb9d3d921224	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-639-30	63187063930	30 TABLET, FILM COATED in 1 BOTTLE (63187-639-30)	2018-12-01	0000-00-00	No	No	Current
63187-639-60	63187063960	60 TABLET, FILM COATED in 1 BOTTLE (63187-639-60)	2018-12-01	0000-00-00	No	No	Current
63187-639-90	63187063990	90 TABLET, FILM COATED in 1 BOTTLE (63187-639-90)	2018-12-01	0000-00-00	No	No	Current