Clopidogrel bisulfate

Product NDC: 77771-124
11-digit product format: 777710124
Labeler code: 77771
Product ID: 77771-124_09ac9273-240e-b149-e063-6394a90a20cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RADHA PHARMACEUTICALS, INC.
Application: ANDA204165
Marketing category: ANDA
Marketing start: 2023-02-20
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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-09-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2014-09-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204165-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204165-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 77771-124
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
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

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 · 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
16aef4f6-6b90-4d5f-9e07-c9927adf3841	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
77771-124-10	Clopidogrel bisulfate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2
77771-124-30	Clopidogrel bisulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
77771-124-90	Clopidogrel bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
77771-124-10	EA - Each	77771-124	59521ceb-4b62-4fe4-acd6-e945fd7c4ae8	1	2023-05-05
77771-124-30	EA - Each	77771-124	244f16ba-4bc6-477b-a48f-328ab111c734	1	2023-05-05
77771-124-90	EA - Each	77771-124	d4f2c25c-0c34-44e3-bc31-0cf85832ebf7	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77771-124	CLOPIDOGREL BISULFATE TABLET, FILM COATED [RADHA PHARMACEUTICALS, INC.]	2	Current NDC, 3 package rows	20231109_16aef4f6-6b90-4d5f-9e07-c9927adf3841.zip

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	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2
309362	clopidogrel 75 MG Oral Tablet	PSN	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2
749196	clopidogrel 300 MG Oral Tablet	SCD	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2
309362	clopidogrel 75 MG Oral Tablet	SCD	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2
749196	clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet	SY	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
77771-124-10	77771012410	1000 TABLET, FILM COATED in 1 BOTTLE (77771-124-10)	2023-02-20	No	No	Current
77771-124-30	77771012430	30 TABLET, FILM COATED in 1 BOTTLE (77771-124-30)	2023-02-20	No	No	Current
77771-124-90	77771012490	90 TABLET, FILM COATED in 1 BOTTLE (77771-124-90)	2023-02-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel bisulfate	RADHA PHARMACEUTICALS, INC. \| ScieGen Pharmaceuticals, INC.	2023-11-08	HUMAN PRESCRIPTION DRUG LABEL	2