Plavix

Product NDC: 53808-0763
11-digit product format: 538080763
Labeler code: 53808
Product ID: 53808-0763_510501a7-61be-4fa1-8120-4bd218a01d8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA020839
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: CLOPIDOGREL BISULFATE
Active strength: 75 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0763		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0763	53808-0763-1	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0763-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0763-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0763-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0763-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0763-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0763-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0763-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0763-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0763-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0763-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0763-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0763-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0763-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0763-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0763-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0763-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0763-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0763-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0763-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0763-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0763-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0763-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020839-001	PLAVIX	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17
N020839-002	PLAVIX	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020839-001	AB
N020839-002	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 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2007-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020839-001	PLAVIX	EQ 75MG BASE	TABLET / ORAL	AB	RLD	1997-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020839-002	PLAVIX	EQ 300MG BASE	TABLET / ORAL	AB	RLD	2007-09-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020839-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020839-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020839-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020839-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020839-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020839-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020839-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020839-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020839-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020839-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020839-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020839-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020839-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020839-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020839-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020839-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020839-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020839-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020839-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020839-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020839-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020839-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020839-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020839-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020839-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020839-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020839-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020839-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020839-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020839-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020839-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020839-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020839-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020839-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020839-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020839-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020839-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020839-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020839-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020839-001	6429210	2019-06-10	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-001	6504030	2019-06-10	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-001	6429210*PED	2019-12-10	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-001	6504030*PED	2019-12-10	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	6429210	2019-06-10	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	6504030	2019-06-10	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	6429210*PED	2019-12-10	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020839-002	6504030*PED	2019-12-10	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020839-001	6429210	2019-06-10	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-001	6504030	2019-06-10	Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-001	6429210*PED	2019-12-10	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-001	6504030*PED	2019-12-10	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-002	6429210	2019-06-10	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-002	6504030	2019-06-10	Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-002	6429210*PED	2019-12-10	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020839-002	6504030*PED	2019-12-10	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020839-001	6429210	2019-06-10	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-001	6504030	2019-06-10	Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-001	6429210*PED	2019-12-10	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-001	6504030*PED	2019-12-10	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-002	6429210	2019-06-10	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-002	6504030	2019-06-10	Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-002	6429210*PED	2019-12-10	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020839-002	6504030*PED	2019-12-10	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020839-001	6429210	2019-06-10	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-001	6504030	2019-06-10	Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-001	6429210*PED	2019-12-10	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-001	6504030*PED	2019-12-10	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-002	6429210	2019-06-10	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-002	6504030	2019-06-10	Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-002	6429210*PED	2019-12-10	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020839-002	6504030*PED	2019-12-10	Pediatric extension	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0763-1	2019-10-21	C162847	48780-1	956f9ecf-d44f-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use PLAVIX safely and effectively. See full prescribing information for PLAVIX. PLAVIX (clopidogrel bisulfate) tablets Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0763-1	Plavix	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOPIDOGREL BISULFATE	ACTIVE INGREDIENT	08I79HTP27	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
clopidogrel	ACTIVE MOIETY	A74586SNO7	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0763	PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_079ed521-3ff0-47fa-86d5-a336732056cc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plavix	CLOPIDOGREL	Sanofi-Aventis U.S. LLC	de8b0b67-eb25-4684-83b5-7ad785314227	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020839 application number: NDA020839

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	079ed521-3ff0-47fa-86d5-a336732056cc	1
213169	Plavix 75 MG Oral Tablet	PSN	079ed521-3ff0-47fa-86d5-a336732056cc	1
213169	clopidogrel 75 MG Oral Tablet [Plavix]	SBD	079ed521-3ff0-47fa-86d5-a336732056cc	1
309362	clopidogrel 75 MG Oral Tablet	SCD	079ed521-3ff0-47fa-86d5-a336732056cc	1
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	079ed521-3ff0-47fa-86d5-a336732056cc	1
213169	Plavix 75 MG (clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	079ed521-3ff0-47fa-86d5-a336732056cc	1
213169	Plavix 75 MG Oral Tablet	SY	079ed521-3ff0-47fa-86d5-a336732056cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0763-1	53808076301	30 in 1 BLISTER PACK	Historical