NDC 80425-0113

Zofran

Ondansetron 4mg

Zofran is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Advanced Rx Pharmacy Of Tennessee, Llc. The primary component is Ondansetron.

Product ID80425-0113_b5a70800-9131-0a7c-e053-2995a90aaa1c
NDC80425-0113
Product TypeHuman Prescription Drug
Proprietary NameZofran
Generic NameOndansetron 4mg
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2010-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA090469
Labeler NameAdvanced Rx Pharmacy of Tennessee, LLC
Substance NameONDANSETRON
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 80425-0113-2

60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (80425-0113-2)
Marketing Start Date2010-04-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Zofran" or generic name "Ondansetron 4mg"

NDCBrand NameGeneric Name
0078-0675ZOFRANondansetron hydrochloride
0078-0676ZOFRANondansetron hydrochloride
0078-0679ZOFRANondansetron hydrochloride
0078-0680ZOFRANondansetron hydrochloride
0173-0447ZOFRANondansetron hydrochloride
0173-0489ZOFRANondansetron hydrochloride
80425-0072ZofranOndansetron 4mg
80425-0073ZofranOndansetron OD 4mg
80425-0075ZofranOndansetron HCl 8mg
80425-0113ZofranOndansetron 4mg

Trademark Results [Zofran]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZOFRAN
ZOFRAN
73670524 1592702 Live/Registered
GLAXO GROUP LIMITED
1987-07-06
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