NDC Code(s) : 58118-0921-2, 58118-0921-6, 58118-0922-2, 58118-0922-6
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cefuroxime AxetilCefuroxime Axetil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0921(NDC:64679-921)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL(UNII: Z49QDT0J8Z)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SMCC(UNII: B357P1G1IF)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 11 mm
Flavor Imprint Code W;921
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0921-220 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:58118-0921-660 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065166 07/29/2005
Cefuroxime AxetilCefuroxime Axetil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0922(NDC:64679-922)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL(UNII: Z49QDT0J8Z)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SMCC(UNII: B357P1G1IF)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (capsule) Size 20 mm
Flavor Imprint Code W;922
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0922-220 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:58118-0922-660 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065166 07/29/2005

PRINCIPAL DISPLAY PANEL

250 label

PRINCIPAL DISPLAY PANEL

500 label