NDC Code(s) : 0904-6181-96
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Demeclocycline HydrochlorideDemeclocycline Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6181
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
ALGINIC ACID(UNII: 8C3Z4148WZ)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 20 mm
Flavor Imprint Code AN;54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6181-9648 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065425 11/19/2010

PRINCIPAL DISPLAY PANEL

Demeclocycline Hcl 300 mg Tabs