Doxycycline
DOXYCYCLINE TABLETS Rx only
Approved
Approval ID
8224b9c5-5c4b-4dda-bc58-47b6604c2884
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2018
Manufacturers
FDA
Sun Pharmaceutical Industries Inc.
DUNS: 146974886
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 Code63304-132
Application NumberANDA065356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2018
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-173
Application NumberANDA065356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2018
FDA Product Classification
INGREDIENTS (9)
DOXYCYCLINEActive
Quantity: 150 mg in 1 1
Code: N12000U13O
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-130
Application NumberANDA065356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2018
FDA Product Classification
INGREDIENTS (10)
DOXYCYCLINEActive
Quantity: 50 mg in 1 1
Code: N12000U13O
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Doxycycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-131
Application NumberANDA065356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2018
FDA Product Classification
INGREDIENTS (13)
DOXYCYCLINEActive
Quantity: 75 mg in 1 1
Code: N12000U13O
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT