MedPath
FDA Product

DOXYCYCLINE HYCLATE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

DOXYCYCLINE HYCLATE

42806-646

Regulatory Information

42806-646

ANDA214207

C73584

September 18, 2023

USA

These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS.Initial U.S. Approval: 1967

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

EPIC PHARMA, LLC

827915443

Active Ingredients

DOXYCYCLINE HYCLATE

Quantity: 150 mg in 1 1

Code: 19XTS3T51U

Class Code: ACTIM

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

DOXYCYCLINE ANHYDROUS

Code: 334895S862

© Copyright 2025. All Rights Reserved by MedPath