Doxycycline
Doxycycline Tablets, USP
Approved
Approval ID
bc321932-b600-4659-a499-1853991b4ab9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1121
Application NumberANDA209582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (12)
DOXYCYCLINEActive
Quantity: 50 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1124
Application NumberANDA209582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (12)
DOXYCYCLINEActive
Quantity: 150 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1123
Application NumberANDA209582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (12)
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1122
Application NumberANDA209582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (11)
DOXYCYCLINEActive
Quantity: 75 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT