Clopidogrel

Product NDC: 52605-083
11-digit product format: 526050083
Labeler code: 52605
Product ID: 52605-083_9e3256b5-2032-4615-967d-449d49b09921
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET
Route: ORAL
Labeler: POLYGEN PHARMACEUTICALS INC.
Application: ANDA213351
Marketing category: ANDA
Marketing start: 2021-03-01
Substance: CLOPIDOGREL BISULFATE
Active strength: 300 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
A213351-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2020-07-17
A213351-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2020-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213351-001	AB
A213351-002	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	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2020-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2020-07-17	`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	A213351-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A213351-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clopidogrel	CLOPIDOGREL	POLYGEN PHARMACEUTICALS INC.	56b5d12b-b3fe-4de9-a5ef-80377c72d843	2022-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213351 application number: ANDA213351 ndc (product): 52605-083

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOPIDOGREL BISULFATE	300 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
56b5d12b-b3fe-4de9-a5ef-80377c72d843	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
52605-083-05	Clopidogrel	500 in 1 BOTTLE, DISPENSING	TABLET	500		5
52605-083-13	Clopidogrel	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-083	CLOPIDOGREL TABLET CLOPIDOGREL TABLET [POLYGEN PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 2 package rows	20220730_56b5d12b-b3fe-4de9-a5ef-80377c72d843.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE
A74586SNO7	CLOPIDOGREL	113665-84-2	Clopidogrel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749196	clopidogrel 300 MG Oral Tablet	PSN	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5
309362	clopidogrel 75 MG Oral Tablet	PSN	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5
749196	clopidogrel 300 MG Oral Tablet	SCD	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5
309362	clopidogrel 75 MG Oral Tablet	SCD	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5
749196	clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet	SY	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	56b5d12b-b3fe-4de9-a5ef-80377c72d843	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52605-083-05	52605008305	500 TABLET in 1 BOTTLE, DISPENSING (52605-083-05)	500 tablet	2021-03-01	0000-00-00	No	No	Current
52605-083-13	52605008313	30 TABLET in 1 BOTTLE (52605-083-13)	30 tablet	2021-03-01	0000-00-00	No	No	Current