Doxycycline Hyclate
Doxycycline Hyclate Capsules, USP
Approved
Approval ID
46dff4c0-9aac-20f9-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2017
Manufacturers
FDA
Apotheca Inc.
DUNS: 051457844
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 Code12634-169
Application NumberANDA062500
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOXYCYCLINE HYCLATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2017
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM