doxycycline
doxycycline hyclate capsules
Approved
Approval ID
1496c935-b2dc-e1e4-e063-6394a90a1e49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 26, 2024
Manufacturers
FDA
Medsource Pharmaceuticals
DUNS: 833685915
Products 1
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 Code45865-203
Application NumberANDA209402
Product Classification
M
Marketing Category
C73584
G
Generic Name
doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateMarch 26, 2024
FDA Product Classification
INGREDIENTS (10)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT