DOXYCYCLINE HYCLATE
These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS. DOXYCYCLINE HYCLATE tablets, for oral use Initial U.S. Approval: 1967
Approved
Approval ID
6e587d8d-1a82-4dfa-acea-88704d408f2f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOXYCYCLINE HYCLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-388
Application NumberANDA211744
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (11)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 150 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DOXYCYCLINE HYCLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-387
Application NumberANDA211744
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 75 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT