Label: ONDANSETRON HCL tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-400-43 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 63304-458
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 11, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-400-43
MFG: 63304-458-30
Ondansetron 4 MG
3 Tablets
RX Only
Dosage: See package insert
Store at 68 to 77 degrees F.
Keep out of the reach of children.
Each film-coated tablet contains 5 mg of ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron.
Mfg. by Natco Pharma Ltd. Kothur 509 228 A. P. India for Ranbaxy Pharmaceuticals, Jacksonville FL 33257 Lot # 404048
Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256
Lot# NW25310001
Exp Date: 07/2015
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ONDANSETRON HCL
ondansetron hcl tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-400(NDC:63304-458) Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON 4 mg in 3 Product Characteristics Color white Score no score Shape OVAL Size 10mm Flavor Imprint Code NO;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-400-43 3 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077851 03/17/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmceuticals 036986393 repack(51655-400)