NDC 70518-2101

Prozac

Fluoxetine Hydrochloride

Prozac is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID70518-2101_89a84ba9-d565-381a-e053-2a95a90a4b84
NDC70518-2101
Product TypeHuman Prescription Drug
Proprietary NameProzac
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-05-22
Marketing CategoryNDA / NDA
Application NumberNDA018936
Labeler NameREMEDYREPACK INC.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2101-0

30 CAPSULE in 1 BLISTER PACK (70518-2101-0)
Marketing Start Date2019-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2101-0 [70518210100]

Prozac CAPSULE
Marketing CategoryNDA
Application NumberNDA018936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-22

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:ddd62d87-c93d-4d0b-ab59-769121e8f4d0
Manufacturer
UNII

Pharmacological Class

  • Serotonin Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]
  • Serotonin Reuptake Inhibitor [EPC]
  • Serotonin Uptake Inhibitors [MoA]

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

NDCBrand NameGeneric Name
0002-3004ProzacFluoxetine hydrochloride
0777-3104ProzacFluoxetine hydrochloride
0777-3105ProzacFluoxetine hydrochloride
0777-3107ProzacFluoxetine hydrochloride
70518-2101ProzacProzac
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
0430-0210SARAFEMfluoxetine hydrochloride
0430-0215SARAFEMfluoxetine hydrochloride
0430-0220SARAFEMfluoxetine hydrochloride

Trademark Results [Prozac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROZAC
PROZAC
75624452 2298322 Live/Registered
ELI LILLY AND COMPANY
1999-01-20
PROZAC
PROZAC
73520776 1357582 Live/Registered
ELI LILLY AND COMPANY
1985-02-04
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