Erythromycin Ethylsuccinate (Page 4 of 4)

HOW SUPPLIED

Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL , dry powder is supplied as white to off-white granules. Reconstituted suspension is off-white to light pink colored suspension.

It is available as follows:

100 mL Bottles (when mixed): NDC 69238-1503-1

Erythromycin ethylsuccinate for oral suspension, USP, 400 mg/5 mL , dry powder is supplied as white to off-white granules. Reconstituted suspension is off-white to light pink colored suspension.

It is available as follows:

100 mL Bottles: NDC 69238-1504-2

Recommended Storage:

Store erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL and 400 mg/5 mL, prior to mixing, below 86°F (30°C). After reconstitution, erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL and 400 mg/5 mL must be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and used within 35 days; refrigeration is not required.

REFERENCES

  1. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
  2. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999;354 (9196): 2101-5

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 04-2018-00

PRINCIPAL DISPLAY PANEL

200 mg Label
(click image for full-size original)

400 mg Label
(click image for full-size original)
ERYTHROMYCIN ETHYLSUCCINATE
erythromycin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1503
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN) ERYTHROMYCIN 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
SUCROSE
XANTHAN GUM
SODIUM CITRATE
Product Characteristics
Color white (White to off-white granules) Score
Shape Size
Flavor FRUIT (mixed-fruit flavor) , CARAMEL Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1503-1 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211204 11/04/2019
ERYTHROMYCIN ETHYLSUCCINATE
erythromycin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN) ERYTHROMYCIN 400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
SUCROSE
XANTHAN GUM
SODIUM CITRATE
Product Characteristics
Color white (White to off-white granules) Score
Shape Size
Flavor BANANA, CARAMEL Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1504-2 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211204 11/04/2019
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 12/2023 Amneal Pharmaceuticals NY LLC

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