NDC 0378-3627

Clopidogrel Bisulfate

Clopidogrel

Clopidogrel Bisulfate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Clopidogrel Bisulfate.

• Product ID: 0378-3627_8a954eb8-6620-431e-ad3e-d6c634de4f1d
• NDC: 0378-3627
• Product Type: Human Prescription Drug
• Proprietary Name: Clopidogrel Bisulfate
• Generic Name: Clopidogrel
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-04-14
• Marketing End Date: 2019-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077665
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: CLOPIDOGREL BISULFATE
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0378-3627-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3627-77)

• Marketing Start Date: 2015-04-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3627-77 [00378362777]

Clopidogrel Bisulfate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-14
• Marketing End Date: 2019-09-30

NDC 0378-3627-93 [00378362793]

Clopidogrel Bisulfate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-14
• Marketing End Date: 2015-09-16

NDC 0378-3627-05 [00378362705]

Clopidogrel Bisulfate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-04-14
• Marketing End Date: 2019-09-30

Drug Details

Active Ingredients

Ingredient	Strength
CLOPIDOGREL BISULFATE	75 mg/1

OpenFDA Data

• SPL SET ID: a9a3c560-2408-4dd0-9f83-ee3e3a549c7b
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 08I79HTP27
• RxNorm Concept Unique ID - RxCUI:
  • 749196
  • 309362

Pharmacological Class

• Decreased Platelet Aggregation [PE]
• P2Y12 Platelet Inhibitor [EPC]
• P2Y12 Receptor Antagonists [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]

NDC Crossover Matching brand name "Clopidogrel Bisulfate" or generic name "Clopidogrel"

NDC	Brand Name	Generic Name
0378-3627	Clopidogrel Bisulfate	clopidogrel
0904-6294	Clopidogrel Bisulfate	Clopidogrel Bisulfate
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate
68071-4057	Clopidogrel bisulfate	Clopidogrel bisulfate
68071-4268	Clopidogrel Bisulfate	Clopidogrel Bisulfate
68151-3118	Clopidogrel bisulfate	Clopidogrel bisulfate
68788-7238	Clopidogrel Bisulfate	Clopidogrel Bisulfate
68788-9785	Clopidogrel bisulfate	Clopidogrel bisulfate
69117-1010	Clopidogrel bisulfate	Clopidogrel bisulfate
70400-101	Clopidogrel bisulfate	Clopidogrel bisulfate
70518-0195	Clopidogrel Bisulfate	Clopidogrel Bisulfate
70518-0717	Clopidogrel bisulfate	Clopidogrel bisulfate
70518-0990	Clopidogrel Bisulfate	Clopidogrel Bisulfate
70518-1079	Clopidogrel Bisulfate	Clopidogrel Bisulfate
71399-7500	Clopidogrel bisulfate	Clopidogrel bisulfate
71335-0752	Clopidogrel Bisulfate	Clopidogrel Bisulfate
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate
43353-269	clopidogrel bisulfate	clopidogrel bisulfate
47335-894	Clopidogrel Bisulfate	Clopidogrel Bisulfate
50228-124	Clopidogrel bisulfate	Clopidogrel bisulfate
50228-121	Clopidogrel bisulfate	Clopidogrel bisulfate
51079-558	Clopidogrel Bisulfate	Clopidogrel Bisulfate
53808-1002	Clopidogrel bisulfate	Clopidogrel bisulfate
53808-0806	Clopidogrel Bisulfate	Clopidogrel Bisulfate
55154-3376	Clopidogrel Bisulfate	Clopidogrel Bisulfate
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate
55154-5388	Clopidogrel Bisulfate	Clopidogrel Bisulfate
60429-301	clopidogrel bisulfate	clopidogrel bisulfate
62034-017	Clopidogrel bisulfate	Clopidogrel bisulfate
62034-015	clopidogrel bisulfate	clopidogrel bisulfate
63187-639	Clopidogrel bisulfate	Clopidogrel bisulfate
67046-099	Clopidogrel bisulfate	Clopidogrel bisulfate
50090-1300	Clopidogrel Bisulfate	Clopidogrel Bisulfate
70518-2136	Clopidogrel bisulfate	Clopidogrel bisulfate
71335-1232	Clopidogrel bisulfate	Clopidogrel bisulfate
63629-8045	Clopidogrel bisulfate	Clopidogrel bisulfate
0093-7314	Clopidogrel	Clopidogrel
0615-7719	Clopidogrel	Clopidogrel
0615-8014	Clopidogrel	clopidogrel bisulfate
0904-6467	Clopidogrel	clopidogrel bisulfate
16714-052	Clopidogrel	Clopidogrel
16729-218	Clopidogrel	Clopidogrel
16729-219	Clopidogrel	Clopidogrel
31722-901	clopidogrel	clopidogrel
31722-902	clopidogrel	clopidogrel
33261-987	Clopidogrel	Clopidogrel Bisulfate
33342-060	Clopidogrel	Clopidogrel
0024-1171	Plavix	clopidogrel
0024-1332	Plavix	clopidogrel