NDC 49909-005

Fluoxetine HCl

Fluoxetine Hcl

Fluoxetine HCl is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Edgemont Pharmaceuticals, Llc. The primary component is Fluoxetine Hydrochloride.

• Product ID: 49909-005_f0a88a56-7590-d699-a012-480627956b9c
• NDC: 49909-005
• Product Type: Human Prescription Drug
• Proprietary Name: Fluoxetine HCl
• Generic Name: Fluoxetine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-14
• Marketing End Date: 2020-02-29
• Marketing Category: NDA / NDA
• Application Number: NDA202133
• Labeler Name: Edgemont Pharmaceuticals, LLC
• Substance Name: FLUOXETINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 49909-005-30

30 TABLET, FILM COATED in 1 BOTTLE (49909-005-30)

• Marketing Start Date: 2011-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49909-005-30 [49909000530]

Fluoxetine HCl TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202133
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-14
• Marketing End Date: 2020-02-29

Drug Details

Active Ingredients

Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: abccfe74-aaf9-4729-a196-2d666f9562b5
• Manufacturer:
  • Edgemont Pharmaceuticals, LLC
• UNII:
  • I9W7N6B1KJ
• RxNorm Concept Unique ID - RxCUI:
  • 1190110
• UPC Code:
  • 0349909005304

Pharmacological Class

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

Medicade Reported Pricing

49909000530 FLUOXETINE HCL 60 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Fluoxetine HCl" or generic name "Fluoxetine Hcl"

NDC	Brand Name	Generic Name
49909-005	Fluoxetine HCl	Fluoxetine HCl
52427-576	Fluoxetine HCl	Fluoxetine HCl
61919-490	FLUOXETINE HCL	FLUOXETINE HCL