Doxycycline Hyclate
These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS safely and effectively. See Full Prescribing Information for DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS. DOXYCYCLINE HYCLATE delayed-release tablets, for oral use. Initial U.S. Approval: 1967
Approved
Approval ID
4fa26176-a730-48ed-9659-e2f64212f418
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2018
Manufacturers
FDA
Sonoma Pharmaceuticals, Inc.
DUNS: 081642964
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 Code69668-515
Application NumberANDA207494
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2018
FDA Product Classification
INGREDIENTS (13)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)Inactive
Code: 8LDD2V82F5
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 150 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM