Cefuroxime Axetil (Page 6 of 6)

Cefuroxime axetil

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Cefuroxime axetil

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CEFUROXIME AXETIL cefuroxime axetil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2157(NDC:67877-216)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CALCIUM STEARATE
CALCIUM CARBONATE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
PROPYLENE GLYCOL
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 203
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2157-0 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065496 12/01/2010
CEFUROXIME AXETIL cefuroxime axetil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2158(NDC:67877-215)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
SILICON DIOXIDE
CALCIUM STEARATE
CALCIUM CARBONATE
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
PROPYLENE GLYCOL
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 204
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2158-0 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-2158-3 14 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065496 12/01/2010
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2158), RELABEL (50090-2157), REPACK (50090-2157), REPACK (50090-2158)

Revised: 08/2021 A-S Medication Solutions

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