NDC Code(s) : 58118-1962-2, 58118-1962-0
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ClarithromycinClarithromycin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-1962(NDC:0781-1962)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A) 		CLARITHROMYCIN500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code GG;C9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-1962-220 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/08/2005
2NDC:58118-1962-01 in 1 PACKET Type 0: Not a Combination Product25/08/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065136 08/25/2005 06/22/2017

PRINCIPAL DISPLAY PANEL

Clarithromycin Tablets 250 mg LabelClarithromycin Tablets 250 mg Label