NDC 0430-0215

SARAFEM

Fluoxetine Hydrochloride

SARAFEM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID0430-0215_99d6b0f2-48c2-4be9-8025-994c093995d1
NDC0430-0215
Product TypeHuman Prescription Drug
Proprietary NameSARAFEM
Generic NameFluoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-24
Marketing CategoryNDA /
Application NumberNDA021860
Labeler NameAllergan, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength15 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0430-0215-14

4 BLISTER PACK in 1 CARTON (0430-0215-14) > 7 TABLET in 1 BLISTER PACK
Marketing Start Date2009-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0430-0215-14 [00430021514]

SARAFEM TABLET
Marketing CategoryNDA
Application NumberNDA021860
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-24
Marketing End Date2011-03-15

NDC 0430-0215-95 [00430021595]

SARAFEM TABLET
Marketing CategoryNDA
Application NumberNDA021860
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-24
Marketing End Date2011-03-15

Drug Details

NDC Crossover Matching brand name "SARAFEM" or generic name "Fluoxetine Hydrochloride"

NDCBrand NameGeneric Name
0430-0210SARAFEMfluoxetine hydrochloride
0430-0215SARAFEMfluoxetine hydrochloride
0430-0220SARAFEMfluoxetine hydrochloride
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
0615-1357fluoxetinefluoxetine hydrochloride
0615-1384FluoxetineFluoxetine Hydrochloride
0615-8183FluoxetineFluoxetine Hydrochloride
0378-5410Fluoxetine Hydrochloridefluoxetine hydrochloride
0378-5420Fluoxetine Hydrochloridefluoxetine hydrochloride
0615-1387Fluoxetine HydrochlorideFluoxetine Hydrochloride
0781-2822Fluoxetine HydrochlorideFluoxetine Hydrochloride
0781-2823Fluoxetine HydrochlorideFluoxetine Hydrochloride
0781-2824Fluoxetine HydrochlorideFluoxetine Hydrochloride
0832-0402Fluoxetine HydrochlorideFluoxetine Hydrochloride
0002-3004ProzacFluoxetine hydrochloride
0777-3104ProzacFluoxetine hydrochloride
0777-3105ProzacFluoxetine hydrochloride
0777-3107ProzacFluoxetine hydrochloride

Trademark Results [SARAFEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SARAFEM
SARAFEM
75547314 2470102 Live/Registered
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
1998-09-03
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