Biaxin
BIAXIN® Filmtab®(clarithromycin tablets, USP)BIAXIN® XL Filmtab®(clarithromycin extended-release tablets)BIAXIN® Granules(clarithromycin for oral suspension, USP)
Approved
Approval ID
2e899f4a-a2e9-445c-a0ed-6ad811e997e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 5
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 Code54868-3820
Application NumberNDA050662
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (16)
CLARITHROMYCINActive
Quantity: 250 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4191
Application NumberNDA050775
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (10)
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2338
Application NumberNDA050662
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (12)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CLARITHROMYCINActive
Quantity: 500 mg in 1 1
Code: H1250JIK0A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3384
Application NumberNDA050698
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (9)
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CLARITHROMYCINActive
Quantity: 250 mg in 5 mL
Code: H1250JIK0A
Classification: ACTIB
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Clarithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4919
Application NumberNDA050698
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clarithromycin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (9)
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CLARITHROMYCINActive
Quantity: 125 mg in 5 mL
Code: H1250JIK0A
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT