FIDOQUEL-CA1
FIDOQUEL™-CA1 (phenobarbital tablets)
Approved
Approval ID
74450a05-cd1f-44cd-8d65-8d9b370ac44f
Product Type
PRESCRIPTION ANIMAL DRUG LABEL
Effective Date
Mar 25, 2025
Manufacturers
FDA
Genus Lifesciences
DUNS: 113290444
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-563
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITALActive
Quantity: 100 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-541
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-542
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITALActive
Quantity: 32.4 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-562
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 60 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-560
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 15 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-543
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 64.8 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-544
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITALActive
Quantity: 97.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-561
Application NumberNADA141578
Product Classification
M
Marketing Category
C73588
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2025
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 30 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT