clopidogrel

Product NDC: 52605-082
11-digit product format: 526050082
Labeler code: 52605
Product ID: 52605-082_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
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52605-082		D	Discontinued by firm	2026-10-15
excluded package	package	52605-082	52605-082-10	D	Discontinued by firm	2026-10-15
excluded package	package	52605-082	52605-082-13	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Product history page 1 of 2 · 80 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
2026-10-15 13:18:30	2026-09	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A213351-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213351-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213351-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213351-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213351-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213351-002	AB	1	`87673890dc5c…`
2020-11-12 02:37 UTC	2020-11	A213351-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213351-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213351-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213351-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213351-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213351-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213351-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213351-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213351-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213351-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213351-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213351-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213351-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213351-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213351-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213351-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213351-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213351-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213351-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213351-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213351-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213351-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213351-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213351-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213351-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213351-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213351-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213351-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213351-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213351-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
52605-082-10	clopidogrel	1000 in 1 BOTTLE, DISPENSING	TABLET	1000		5
52605-082-13	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
52605-082	CLOPIDOGREL TABLET CLOPIDOGREL TABLET [POLYGEN PHARMACEUTICALS INC.]	5	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
52605-082-10	52605008210	1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10)	1000 tablet	2021-03-01	0000-00-00	No	No	Current
52605-082-13	52605008213	30 TABLET in 1 BOTTLE (52605-082-13)	30 tablet	2021-03-01	0000-00-00	No	No	Current