NDC Code(s) : 42806-143-30, 42806-143-01, 42806-143-05, 42806-144-30, 42806-144-48, 42806-144-01
Packager : Epic Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Demeclocycline HydrochlorideDemeclocycline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE(UNII: 29O079NTYT)
(DEMECLOCYCLINE - UNII:5R5W9ICI6O) 		DEMECLOCYCLINE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
CARNAUBA WAX(UNII: R12CBM0EIZ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C RED NO. 27(UNII: 2LRS185U6K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
POLYDEXTROSE(UNII: VH2XOU12IE)
Product Characteristics
Color RED Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code E143
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-143-3030 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
2NDC:42806-143-01100 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
3NDC:42806-143-05500 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065447 02/02/2015
Demeclocycline HydrochlorideDemeclocycline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-144
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE(UNII: 29O079NTYT)
(DEMECLOCYCLINE - UNII:5R5W9ICI6O) 		DEMECLOCYCLINE HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
CARNAUBA WAX(UNII: R12CBM0EIZ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C RED NO. 27(UNII: 2LRS185U6K)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
POLYDEXTROSE(UNII: VH2XOU12IE)
Product Characteristics
Color RED Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code E144
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-144-3030 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
2NDC:42806-144-4848 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
3NDC:42806-144-01100 in 1 BOTTLE Type 0: Not a Combination Product02/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065447 02/02/2015

LABELER - Epic Pharma, LLC(827915443)

REGISTRANT - Epic Pharma, LLC(827915443)

Establishment
Name Address ID/FEI Business Operations
Epic Pharma, LLC 827915443 MANUFACTURE(42806-143, 42806-144)

PRINCIPAL DISPLAY PANEL

150mg-100ct

PRINCIPAL DISPLAY PANEL

300mg-48ct