Doxycycline Hyclate
DOXYCYCLINE HYCLATE CAPSULES, USP
Approved
Approval ID
1f8f275a-0ea8-4618-a078-ad450d2a434c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 18, 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 Code42582-216
Application NumberANDA209402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2021
FDA Product Classification
INGREDIENTS (8)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Doxycycline HyclateActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT