Doxycycline Hyclate
DOXYCYCLINE HYCLATE CAPSULES, USP
Approved
Approval ID
41fd9969-059c-47a6-a424-4382804407c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2015
Manufacturers
FDA
VersaPharm Incorporated
DUNS: 956741896
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 Code61748-111
Application NumberANDA062396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2015
FDA Product Classification
INGREDIENTS (16)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT