CLOPIDOGREL

Product NDC: 67877-276
Requested package NDC: 67877-276-90
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…`

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

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 · 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): 67877-276-90 ndc (product): 67877-276 ndc11 (package): 67877027690
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

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
67877-276-90	67877027690	90 TABLET in 1 BOTTLE (67877-276-90)	90 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