Ondansetron Hydrochloride (Page 6 of 6)

REFERENCES

  1. Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther. 1997;61:228.
  2. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg. 1973;60:646-649.
  3. Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther. 1999;65:377-381.
  4. De Witte JL, Schoenmaekers B, Sessler DI, et al. Anesth Analg. 2001;92:1319-1321.
  5. Arcioni R, della Rocca M, Romanò R, et al. Anesth Analg. 2002;94:1553-1557.

12-2008M

7333

Sandoz Inc.

Princeton, NJ 08540

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

label
(click image for full-size original)

ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-991(NDC:0781-1679)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 4 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 927;GG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-991-03 3 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077517 06/25/2007
Labeler — H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Operations
Sandoz Inc 110342024 MANUFACTURE

Revised: 12/2011 H.J. Harkins Company, Inc.

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