Doxycycline
DOXYCYCLINE HYCLATETABLETS, USP
Approved
Approval ID
fafe6400-b7c9-485c-b76e-0b85b29db801
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2011
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 1
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 Code68387-381
Application NumberANDA065095
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline hyclate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2011
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT