Doxycycline Hyclate
Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
Approved
Approval ID
a2161675-505c-3d65-e053-2995a90aa644
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-5232
Application NumberANDA062500
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (18)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT