Doxycycline Monohydrate
Revised: January 2012 191157-4
Approved
Approval ID
96424d21-3fa4-4a32-8b98-fd593748f236
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6190
Application NumberNDA050641
Product Classification
M
Marketing Category
C73605
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2012
FDA Product Classification
INGREDIENTS (9)
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT