Clopidogrel

Product NDC: 16714-052
11-digit product format: 167140052
Labeler code: 16714
Product ID: 16714-052_dbf6d86e-5d4f-40da-a933-b928843053b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA202928
Marketing category: ANDA
Marketing start: 2022-08-09
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: 2026-12-31
Current FDA listing: Yes

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
A202928-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202928-001	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	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`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	A202928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202928-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clopidogrel
Listing expiration: 2026-12-31

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
d176de1d-b1b3-4aa9-b783-d53f65a79e50	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
16714-052-01	Clopidogrel	30 in 1 BOTTLE	TABLET	30	6
16714-052-02	Clopidogrel	90 in 1 BOTTLE	TABLET	90	6
16714-052-03	Clopidogrel	500 in 1 BOTTLE	TABLET	500	6
16714-052-04	Clopidogrel	1000 in 1 BOTTLE	TABLET	1000	6
16714-052-10	Clopidogrel	10 in 1 BLISTER PACK	TABLET	10	6
16714-052-11	Clopidogrel	100 in 1 BOX, UNIT-DOSE	TABLET	100	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-052-01	EA - Each	16714-052	38866f04-d562-4b06-8f69-949646f20cd4	1	2023-03-13
16714-052-02	EA - Each	16714-052	34fd1832-9deb-4bc9-92bc-a38192161cba	1	2023-03-13
16714-052-03	EA - Each	16714-052	e88db85b-bdcd-4f97-89d1-d58ba644e313	1	2023-03-13
16714-052-04	EA - Each	16714-052	028a8a0d-f666-4354-872c-0169452f1018	1	2023-12-05
16714-052-10	EA - Each	16714-052	e39ef55a-7525-492e-aad5-dc8e40aead6f	1	2024-12-10
16714-052-11	EA - Each	16714-052	c698506c-4bc5-4372-a633-81d0dc72a33f	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-052	CLOPIDOGREL TABLET [NORTHSTAR RXLLC]	6	Current NDC, Legacy NDC, 6 package rows	20241122_d176de1d-b1b3-4aa9-b783-d53f65a79e50.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL	Redpharm Drug	55731d95-0c99-ff61-e063-6394a90a1ab5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	NorthStar RxLLC	d176de1d-b1b3-4aa9-b783-d53f65a79e50	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928 ndc (product): 16714-052
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	02f0eaf8-0fc2-425d-8259-cef00156e25d	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3aef6fd4-7160-4678-9362-ca76174bfd0e	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3c8c68ca-aa48-43f0-977d-2608e1666be4	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	Bryant Ranch Prepack	85df051d-0fa9-41b3-8862-9d6ca851a9cc	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	Macleods Pharmaceuticals Limited	063cd1eb-98fd-422e-8145-bba04c497efe	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928

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
309362	clopidogrel 75 MG Oral Tablet	PSN	d176de1d-b1b3-4aa9-b783-d53f65a79e50	6
309362	clopidogrel 75 MG Oral Tablet	SCD	d176de1d-b1b3-4aa9-b783-d53f65a79e50	6
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	d176de1d-b1b3-4aa9-b783-d53f65a79e50	6
309362	clopidogrel 75 MG Oral Tablet	PSN	3aef6fd4-7160-4678-9362-ca76174bfd0e	4
309362	clopidogrel 75 MG Oral Tablet	SCD	3aef6fd4-7160-4678-9362-ca76174bfd0e	4
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	3aef6fd4-7160-4678-9362-ca76174bfd0e	4
309362	clopidogrel 75 MG Oral Tablet	PSN	3c8c68ca-aa48-43f0-977d-2608e1666be4	3
309362	clopidogrel 75 MG Oral Tablet	SCD	3c8c68ca-aa48-43f0-977d-2608e1666be4	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	3c8c68ca-aa48-43f0-977d-2608e1666be4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-052-01	16714005201	30 TABLET in 1 BOTTLE (16714-052-01)	30 tablet	2022-08-09	0000-00-00	No	No	Current
16714-052-02	16714005202	90 TABLET in 1 BOTTLE (16714-052-02)	90 tablet	2022-08-09	0000-00-00	No	No	Current
16714-052-03	16714005203	500 TABLET in 1 BOTTLE (16714-052-03)	500 tablet	2022-08-09	0000-00-00	No	No	Current
16714-052-04	16714005204	1000 TABLET in 1 BOTTLE (16714-052-04)	1000 tablet	2023-04-25		No	No	Current
16714-052-10	16714005210	10 TABLET in 1 BLISTER PACK (16714-052-10)	10 tablet	2022-08-09		No	No	Current
16714-052-11	16714005211	100 TABLET in 1 BOX, UNIT-DOSE (16714-052-11)	100 tablet	2022-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	Redpharm Drug	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	1
Clopidogrel	NorthStar RxLLC \| Macleods Pharmaceuticals Limited	2024-11-21	Human Prescription Drug Label	6
Clopidogrel	A-S Medication Solutions	2024-09-29	Human Prescription Drug Label	4
Clopidogrel	A-S Medication Solutions	2024-09-29	Human Prescription Drug Label	3