CLOPIDOGREL

Product NDC: 67877-276
Requested package NDC: 67877-276-05
11-digit product format: 678770276
Labeler code: 67877
Product ID: 67877-276_04c45152-3a50-45e1-9edb-2ddf3ed43988
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOPIDOGREL BISULFATE
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA203632
Marketing category: ANDA
Marketing start: 2024-05-16
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203632-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2023-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203632-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203632-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2023-12-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203632-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203632-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203632-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203632-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203632-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203632-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203632-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203632-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203632-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203632-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203632-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203632-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203632-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203632-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203632-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203632-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203632-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOPIDOGREL	CLOPIDOGREL BISULFATE	Ascend Laboratories, LLC	db1161c9-6efd-4361-a766-6a37c241ccee	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203632 application number: ANDA203632 ndc (package): 67877-276-05 ndc (product): 67877-276 ndc11 (package): 67877027605
CLOPIDOGREL	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	669f0bc6-f173-484d-8efe-c006683b25d1	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203632 application number: ANDA203632
CLOPIDOGREL	CLOPIDOGREL BISULFATE	A-S Medication Solutions	ffeb2fca-d475-4d93-913d-0048ff9fcee9	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203632 application number: ANDA203632
CLOPIDOGREL	CLOPIDOGREL BISULFATE	A-S Medication Solutions	2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203632 application number: ANDA203632

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 · 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
db1161c9-6efd-4361-a766-6a37c241ccee	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
67877-276-05	CLOPIDOGREL	500 in 1 BOTTLE	TABLET	500	8
67877-276-30	CLOPIDOGREL	30 in 1 BOTTLE	TABLET	30	8
67877-276-90	CLOPIDOGREL	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-276-05	EA - Each	67877-276	f04ead37-2c78-448b-9890-759fb8874608	1	2024-07-12
67877-276-90	EA - Each	67877-276	9d2a32b5-a8b3-4d90-8314-0b501dae1db2	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-276	CLOPIDOGREL (CLOPIDOGREL BISULFATE) TABLET [ASCEND LABORATORIES, LLC]	8	Current NDC, 3 package rows	20240518_db1161c9-6efd-4361-a766-6a37c241ccee.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
309362	clopidogrel 75 MG Oral Tablet	PSN	2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032	1
309362	clopidogrel 75 MG Oral Tablet	PSN	669f0bc6-f173-484d-8efe-c006683b25d1	1
309362	clopidogrel 75 MG Oral Tablet	PSN	ffeb2fca-d475-4d93-913d-0048ff9fcee9	1
309362	clopidogrel 75 MG Oral Tablet	SCD	2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032	1
309362	clopidogrel 75 MG Oral Tablet	SCD	669f0bc6-f173-484d-8efe-c006683b25d1	1
309362	clopidogrel 75 MG Oral Tablet	SCD	ffeb2fca-d475-4d93-913d-0048ff9fcee9	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	669f0bc6-f173-484d-8efe-c006683b25d1	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	ffeb2fca-d475-4d93-913d-0048ff9fcee9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67877-276-05	67877027605	500 TABLET in 1 BOTTLE (67877-276-05)	500 tablet	2024-05-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOPIDOGREL	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-06-01	Human Prescription Drug Label	9
CLOPIDOGREL	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	1
CLOPIDOGREL	A-S Medication Solutions	2024-12-06	Human Prescription Drug Label	1
CLOPIDOGREL	A-S Medication Solutions	2024-12-06	Human Prescription Drug Label	1