Cefaclor
Cefaclor Capsules USP
Approved
Approval ID
2f61354e-bcb0-41aa-955f-51eabc11387b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2015
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefaclor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-171
Application NumberANDA065146
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
INGREDIENTS (20)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
TERT-BUTYL ALCOHOLInactive
Code: MD83SFE959
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CEFACLORActive
Quantity: 250 mg in 1 1
Code: 69K7K19H4L
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Cefaclor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-172
Application NumberANDA065146
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
INGREDIENTS (32)
CEFACLORActive
Quantity: 500 mg in 1 1
Code: 69K7K19H4L
Classification: ACTIM
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
tert-butyl alcoholInactive
Code: MD83SFE959
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
TERT-BUTYL ALCOHOLInactive
Code: MD83SFE959
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT