Clopidogrel

Product NDC: 33342-060
11-digit product format: 333420060
Labeler code: 33342
Product ID: 33342-060_05355b6d-3802-4542-bda2-cd6a17e57266
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clopidogrel
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202928
Marketing category: ANDA
Marketing start: 2012-10-16
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CLOPIDOGREL BISULFATE	75 mg/1

Field, Values table
Field	Values
Unii	08I79HTP27
Rxcui	309362

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33342-060-07	Clopidogrel	30 in 1 BOTTLE	TABLET	30	15
33342-060-10	Clopidogrel	90 in 1 BOTTLE	TABLET	90	15
33342-060-12	Clopidogrel	100 in 1 BOX, UNIT-DOSE	TABLET	100	15
33342-060-15	Clopidogrel	500 in 1 BOTTLE	TABLET	500	15
33342-060-44	Clopidogrel	1000 in 1 BOTTLE	TABLET	1000	15

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-060-07	EA - Each	33342-060	d25d46da-1510-4c06-9d7c-950e8fa05fc2	1	2015-01-05
33342-060-10	EA - Each	33342-060	b80179fa-5f1d-4c77-ad39-35d5ecb2f97c	1	2015-04-03
33342-060-15	EA - Each	33342-060	423e9710-64ea-4c09-80f7-eca240287154	1	2015-01-05

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOPIDOGREL BISULFATE	ACTIVE INGREDIENT	08I79HTP27	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
CLOPIDOGREL	ACTIVE MOIETY	A74586SNO7	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-060	CLOPIDOGREL TABLET [MACLEODS PHARMACEUTICALS LIMITED]	15	Current NDC, Legacy NDC, 5 package rows	20240321_063cd1eb-98fd-422e-8145-bba04c497efe.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309362	clopidogrel 75 MG Oral Tablet	PSN	063cd1eb-98fd-422e-8145-bba04c497efe	15
309362	clopidogrel 75 MG Oral Tablet	SCD	063cd1eb-98fd-422e-8145-bba04c497efe	15
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	063cd1eb-98fd-422e-8145-bba04c497efe	15
309362	clopidogrel 75 MG Oral Tablet	PSN	02f0eaf8-0fc2-425d-8259-cef00156e25d	9
309362	clopidogrel 75 MG Oral Tablet	SCD	02f0eaf8-0fc2-425d-8259-cef00156e25d	9
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	02f0eaf8-0fc2-425d-8259-cef00156e25d	9
309362	clopidogrel 75 MG Oral Tablet	PSN	85df051d-0fa9-41b3-8862-9d6ca851a9cc	8
309362	clopidogrel 75 MG Oral Tablet	SCD	85df051d-0fa9-41b3-8862-9d6ca851a9cc	8
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	85df051d-0fa9-41b3-8862-9d6ca851a9cc	8
309362	clopidogrel 75 MG Oral Tablet	PSN	5b0caa99-c313-4b39-a6ad-df662823e343	5
309362	clopidogrel 75 MG Oral Tablet	SCD	5b0caa99-c313-4b39-a6ad-df662823e343	5
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	5b0caa99-c313-4b39-a6ad-df662823e343	5
309362	clopidogrel 75 MG Oral Tablet	PSN	f3d1df40-661b-262d-e053-2a95a90a77e7	2
309362	clopidogrel 75 MG Oral Tablet	SCD	f3d1df40-661b-262d-e053-2a95a90a77e7	2
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	f3d1df40-661b-262d-e053-2a95a90a77e7	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-060-07	33342006007	30 TABLET in 1 BOTTLE (33342-060-07)	30 tablet	2012-10-16	0000-00-00	No	No	Current
33342-060-10	33342006010	90 TABLET in 1 BOTTLE (33342-060-10)	90 tablet	2014-09-11	0000-00-00	No	No	Current
33342-060-12	33342006012	100 TABLET in 1 BOX, UNIT-DOSE (33342-060-12)	100 tablet	2012-10-16	0000-00-00	No	No	Current
33342-060-15	33342006015	500 TABLET in 1 BOTTLE (33342-060-15)	500 tablet	2012-10-16	0000-00-00	No	No	Current
33342-060-44	33342006044	1000 TABLET in 1 BOTTLE (33342-060-44)	1000 tablet	2023-05-12		No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clopidogrel	A-S Medication Solutions	2024-10-31	Human Prescription Drug Label	9
Clopidogrel	Redpharm Drug, Inc. \| Redpharm Drug, Inc	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
Clopidogrel	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	8
Clopidogrel	Macleods Pharmaceuticals Limited	2024-03-20	Human Prescription Drug Label	15
Clopidogrel	Unit Dose Services	2017-11-07	Human Prescription Drug Label	5