DOXYCYCLINE
Approved
Approval ID
672c83fb-6673-5ba0-e053-2991aa0ab239
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2018
Manufacturers
FDA
H.J. Harkins Co., Inc.
DUNS: 147681894
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 Code76519-1134
Application NumberANDA204446
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2018
FDA Product Classification
INGREDIENTS (16)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT