Clopidogrel bisulfate

Product NDC: 82009-021
11-digit product format: 820090021
Labeler code: 82009
Product ID: 82009-021_e8fadba0-80b2-f6fd-ba68-512d796e5d89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA076273
Marketing category: ANDA
Marketing start: 2022-11-15
Marketing end: 2027-02-28
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
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82009-021	82009-021-90	D	Discontinued by firm		2026-08-11

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
A076273-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2008-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076273-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076273-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076273-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076273-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076273-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076273-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076273-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076273-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076273-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076273-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076273-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076273-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076273-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076273-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076273-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076273-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076273-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076273-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076273-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076273-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076273-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076273-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076273-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076273-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076273-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076273-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076273-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076273-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076273-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076273-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076273-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076273-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076273-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076273-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076273-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076273-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076273-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076273-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076273-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076273-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076273-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel bisulfate

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
333c7992-d481-b7d4-404f-9a49c85b6331	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	Strength	SPL version
82009-021-05	Clopidogrel bisulfate	500 in 1 BOTTLE	TABLET, FILM COATED	500		4
82009-021-90	Clopidogrel bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82009-021-05	EA - Each	82009-021	1619cf98-cc34-4cd7-99eb-4dcf48735302	1	2023-01-09
82009-021-90	EA - Each	82009-021	56e010b8-3326-42cc-80b6-215dd8a3a0a4	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82009-021	CLOPIDOGREL BISULFATE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240314_333c7992-d481-b7d4-404f-9a49c85b6331.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Quallent Pharmaceuticals Health LLC	333c7992-d481-b7d4-404f-9a49c85b6331	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076273 application number: ANDA076273 ndc (product): 82009-021
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	b5aa951f-72de-bea1-98a2-a4085c64a361	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076273 application number: ANDA076273

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	333c7992-d481-b7d4-404f-9a49c85b6331	4
309362	clopidogrel 75 MG Oral Tablet	SCD	333c7992-d481-b7d4-404f-9a49c85b6331	4
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	333c7992-d481-b7d4-404f-9a49c85b6331	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82009-021-05	82009002105	500 TABLET, FILM COATED in 1 BOTTLE (82009-021-05)	2022-11-15	2027-02-28	No	No	Current
82009-021-90	82009002190	90 TABLET, FILM COATED in 1 BOTTLE (82009-021-90)	2022-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel bisulfate	Quallent Pharmaceuticals Health LLC \| DR. REDDY'S LABORATORIES LIMITED (FTO-Sez-Process Unit-01) \| Dr. Reddy's Laboratories Limited	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	4