Doxycycline Hyclate
DOXYCYCLINE HYCLATE TABLETS, USP
Approved
Approval ID
4ee17bbb-29ba-49ce-8f81-748879831314
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 19, 2021
Manufacturers
FDA
Bi-Coastal Pharma International, LLC
DUNS: 078397428
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 Code42582-215
Application NumberANDA211343
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2021
FDA Product Classification
INGREDIENTS (7)
Doxycycline HyclateActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT