NDC Code(s) : 43063-110-06
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

E.E.S.Erythromycin Ethylsuccinate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-110(NDC:0074-5729)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN ETHYLSUCCINATE(UNII: 1014KSJ86F)
(ERYTHROMYCIN - UNII:63937KV33D) 		ERYTHROMYCIN400 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
Product Characteristics
Color pink Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code EE
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-110-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061905 12/16/2010 12/15/2016

PRINCIPAL DISPLAY PANEL

ERYTHROMYCIN ETHYLSUCCINATE TABLETS, USP

400 mg Erythromycin activity

Rx only

43063110 Label