Clopidogrel bisulfate

Product NDC: 43598-122
11-digit product format: 435980122
Labeler code: 43598
Product ID: 43598-122_76e9fa8d-c829-37b1-814e-844d436b7784
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr.Reddy's Laboratories Inc
Application: ANDA091023
Marketing category: ANDA
Marketing start: 2025-04-15
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 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
A091023-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2012-05-17
A091023-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2024-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091023-001	AB
A091023-002	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 · 55 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	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`ea99ee380514…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 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	A091023-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091023-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091023-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091023-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091023-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091023-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091023-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091023-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091023-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091023-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091023-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091023-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091023-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091023-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091023-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091023-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091023-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091023-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091023-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091023-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091023-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091023-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091023-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091023-001	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel bisulfate
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
45caaa95-8470-b459-5f82-8156072d1878	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	SPL version
43598-122-05	Clopidogrel bisulfate	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
43598-122-06	Clopidogrel bisulfate	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	3
43598-122-30	Clopidogrel bisulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
43598-122-59	Clopidogrel bisulfate	5 in 1 CARTON	TABLET, FILM COATED	5	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-122	CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC]	3	Current NDC, 4 package rows	20250416_45caaa95-8470-b459-5f82-8156072d1878.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	e5ee3807-5c9d-4b65-b188-4159a0fb1c85	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Quallent Pharmaceuticals Health LLC	d072b6ea-2bb4-8965-918e-23f9080efcb0	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	McKesson Corporation dba SKY Packaging	823c5dd0-f4e6-9b45-54de-a609caa8fa90	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Inc	45caaa95-8470-b459-5f82-8156072d1878	2025-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023 ndc (product): 43598-122
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	4da4da53-91ae-4d4f-145f-255c5db443a5	2023-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023

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
749196	clopidogrel 300 MG Oral Tablet	PSN	45caaa95-8470-b459-5f82-8156072d1878	3
309362	clopidogrel 75 MG Oral Tablet	PSN	45caaa95-8470-b459-5f82-8156072d1878	3
749196	clopidogrel 300 MG Oral Tablet	SCD	45caaa95-8470-b459-5f82-8156072d1878	3
309362	clopidogrel 75 MG Oral Tablet	SCD	45caaa95-8470-b459-5f82-8156072d1878	3
749196	clopidogrel 300 MG (as clopidogrel bisulfate 391.5 MG) Oral Tablet	SY	45caaa95-8470-b459-5f82-8156072d1878	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	45caaa95-8470-b459-5f82-8156072d1878	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43598-122-05	43598012205	500 TABLET, FILM COATED in 1 BOTTLE (43598-122-05)		2025-04-15	No	No	Current
43598-122-06	43598012206	6 in 1 BLISTER PACK					Historical
43598-122-30	43598012230	30 TABLET, FILM COATED in 1 BOTTLE (43598-122-30)		2025-04-15	No	No	Current
43598-122-59	43598012259	5 BLISTER PACK in 1 CARTON (43598-122-59) / 6 TABLET, FILM COATED in 1 BLISTER PACK (43598-122-06)	5 blister pack	2025-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel bisulfate	Dr.Reddy's Laboratories Inc \| Dr.Reddy's Laboratories Limited-FTO 3	2025-03-07	HUMAN PRESCRIPTION DRUG LABEL	3