Doxycycline Hyclate
Doxycycline Hyclate Capsules, USP Doxycycline Hyclate Tablets, USP
Approved
Approval ID
fa24a981-ea4c-41af-bd1e-4af039bcf767
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2018
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-117
Application NumberANDA062505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (11)
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Doxycycline HyclateActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT