clarithromycin
CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP
Approved
Approval ID
d9db2fd3-a668-4d37-9082-18f6ceb8c3cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-429
Application NumberANDA065145
Product Classification
M
Marketing Category
C73584
G
Generic Name
clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (11)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT