Clopidogrel bisulfate

Product NDC: 63629-8045
11-digit product format: 636298045
Labeler code: 63629
Product ID: 63629-8045_f0d31870-86fa-4079-ae1a-508bc2f64317
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204165
Marketing category: ANDA
Marketing start: 2017-05-05
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-8045		I	Inactivated by FDA		2026-08-17
excluded package	package	63629-8045	63629-8045-1	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 · 30 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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`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	63629-8045-1	`1332a3947898…`	`d4bfe170f9cd…`

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
A204165-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-09-15
A204165-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2014-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204165-001	AB
A204165-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204165-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204165-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2014-09-15	`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	A204165-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204165-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204165-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204165-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204165-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204165-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204165-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204165-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204165-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204165-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204165-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204165-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204165-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204165-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204165-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204165-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204165-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204165-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204165-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204165-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204165-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204165-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204165-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204165-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204165-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204165-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39fa80eb-1490-ce82-3d3a-820ae7c37b85	Product name	5	20250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8045-1	2024-01-30	C162847	48780-1	1030e365-1e89-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8045-1	Clopidogrel bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8045	CLOPIDOGREL BISULFATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2	Legacy NDC, 1 package rows	20220119_f0d31870-86fa-4079-ae1a-508bc2f64317.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Preferred Pharmaceuticals, Inc.	e51d4bcc-01df-409d-9179-45e6536ac25b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NCS HealthCare of KY, LLC dba Vangard Labs	8406b8e3-e203-402f-8858-2748119e2351	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL BISULFATE	AvPAK	94a5cdc4-e063-1d46-e053-2995a90a7e15	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	2969deac-274b-4042-9c90-9522e62a979d	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	a7bf847d-43e9-166e-e053-2995a90a239e	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL BISULFATE	Proficient Rx LP	330702d9-842c-416d-9b11-b4a9b707e9b2	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	539265a6-e356-42cd-bde9-ac704f108c74	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	RADHA PHARMACEUTICALS, INC.	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	7c4b3bc3-8f3b-4232-835d-e37d93b92c3e	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	ScieGen Pharmaceuticals Inc	d03cfc18-c9e4-41f8-b54d-6a7564c32afb	2023-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL BISULFATE	Westminster Pharmaceuticals, LLC	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	2023-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Proficient Rx LP	4842be24-3919-48ae-9302-eb9d3d921224	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165
Clopidogrel	CLOPIDOGREL	Vensun Pharmaceuticals, Inc.	86ee71f2-850e-4c8e-87f3-c7a618d59d95	2019-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204165 application number: ANDA204165

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	f0d31870-86fa-4079-ae1a-508bc2f64317	2
309362	clopidogrel 75 MG Oral Tablet	SCD	f0d31870-86fa-4079-ae1a-508bc2f64317	2
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	f0d31870-86fa-4079-ae1a-508bc2f64317	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8045-1	63629804501	90 TABLET, FILM COATED in 1 BOTTLE (63629-8045-1)	2019-07-25	0000-00-00	No	No	Current