DOXYCYCLINE HYCLATE (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 150 mg 60ct

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DOXYCYCLINE HYCLATE
doxyclycline hyclate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-645
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 75 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code PC90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-645-60 60 TABLET, COATED in 1 BOTTLE None
2 NDC:42806-645-01 100 TABLET, COATED in 1 BOTTLE None
3 NDC:42806-645-05 500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214207 12/16/2020
DOXYCYCLINE HYCLATE
doxyclycline hyclate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-646
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 150 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color GREEN Score 3 pieces
Shape OVAL (capsule-shaped) Size 16mm
Flavor Imprint Code PC;91
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-646-60 60 TABLET, COATED in 1 BOTTLE None
2 NDC:42806-646-01 100 TABLET, COATED in 1 BOTTLE None
3 NDC:42806-646-05 500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214207 12/16/2020
Labeler — EPIC PHARMA, LLC (827915443)
Registrant — EPIC PHARMA, LLC (827915443)
Establishment
Name Address ID/FEI Operations
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe 080230346 MANUFACTURE (42806-645), MANUFACTURE (42806-646)

Revised: 09/2023 EPIC PHARMA, LLC

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