NDC 52427-576

Fluoxetine HCl

Fluoxetine Hcl

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

• Product ID: 52427-576_482c087b-3272-265e-5d4e-874a1edb995d
• NDC: 52427-576
• 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: 2017-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA202133
• Labeler Name: Almatica Pharma Inc.
• Substance Name: FLUOXETINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52427-576-30

30 TABLET, FILM COATED in 1 BOTTLE (52427-576-30)

• Marketing Start Date: 2017-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52427-576-30 [52427057630]

Fluoxetine HCl TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202133
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-01

Drug Details

Active Ingredients

Ingredient	Strength
FLUOXETINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: b47b291f-3340-0c2a-3585-0926b9c1a71f
• Manufacturer:
  • Almatica Pharma Inc.
• UNII:
  • I9W7N6B1KJ
• RxNorm Concept Unique ID - RxCUI:
  • 1190110
• UPC Code:
  • 0352427576300

Pharmacological Class

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

Medicade Reported Pricing

52427057630 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