Amoxicillin
Amoxicillin Capsules, Tablets and Powder for Oral Suspension, USP
Approved
Approval ID
daa89601-3e7c-4d9e-9bed-fd6abf20348e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4155
Application NumberANDA065387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 250 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3109
Application NumberANDA064076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (15)
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5101
Application NumberANDA065378
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3107
Application NumberANDA064076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (15)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4543
Application NumberANDA065228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4468
Application NumberANDA065378
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 200 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4150
Application NumberANDA065387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2012
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 125 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT