Erythrocin Stearate (Page 5 of 5)

FILMTAB-Film-sealed tablets, Abbott.

Abbott Laboratories

North Chicago, IL 60064, U.S.A.

Principal Display Panel

Erythrocin® Stearate Filmtab® (Erythromycin Stearate Tablets, USP) 250mg
28 Tablets
NDC 10544-594-28

250mg 28ct
(click image for full-size original)

Principal Display Panel

Erythrocin® Stearate Filmtab® (Erythromycin Stearate Tablets, USP) 500mg
28 Tablets
NDC 10544-595-28

500mg 28ct
(click image for full-size original)

ERYTHROCIN STEARATE
erythromycin stearate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-594(NDC:0074-6346)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN STEARATE (ERYTHROMYCIN ) ERYTHROMYCIN 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 7
POLACRILIN POTASSIUM
POVIDONES
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM CITRATE
SORBIC ACID
SORBITAN MONOOLEATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
Product Characteristics
Color PINK Score no score
Shape ROUND Size 13mm
Flavor Imprint Code ES
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-594-28 28 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-594-40 40 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA060359 03/09/2010
ERYTHROCIN STEARATE
erythromycin stearate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-595(NDC:0074-6316)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN STEARATE (ERYTHROMYCIN ) ERYTHROMYCIN 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C RED NO. 3
MAGNESIUM HYDROXIDE
POLACRILIN POTASSIUM
POVIDONES
PROPYLENE GLYCOL
SORBITAN MONOOLEATE
TITANIUM DIOXIDE
VANILLIN
Product Characteristics
Color PINK Score no score
Shape OVAL Size 19mm
Flavor Imprint Code ET
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-595-28 28 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA060359 09/14/2010
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-594), repack (10544-595)

Revised: 07/2015 Blenheim Pharmacal, Inc.

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