Clarithromycin
Clarithromycin Tablets, USP
Approved
Approval ID
92ae2611-637c-4a9e-8e95-2d8fa8191f03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5430
Application NumberANDA065136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2012
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB