fluoxetine

Generic: fluoxetine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-699
Product ID 71610-699_7088632f-e68a-40cb-a04f-3321b323a38e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2022-10-24

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610699
Hyphenated Format 71610-699

Supplemental Identifiers

RxCUI
310384 310385
UNII
I9W7N6B1KJ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluoxetine (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-699-30)
  • 60 CAPSULE in 1 BOTTLE (71610-699-53)
  • 90 CAPSULE in 1 BOTTLE (71610-699-60)
  • 120 CAPSULE in 1 BOTTLE (71610-699-70)
  • 180 CAPSULE in 1 BOTTLE (71610-699-80)
  • 270 CAPSULE in 1 BOTTLE (71610-699-92)
source: ndc

Packages (6)

71610-699-30 30 CAPSULE in 1 BOTTLE (71610-699-30) 71610-699-53 60 CAPSULE in 1 BOTTLE (71610-699-53) 71610-699-60 90 CAPSULE in 1 BOTTLE (71610-699-60) 71610-699-70 120 CAPSULE in 1 BOTTLE (71610-699-70) 71610-699-80 180 CAPSULE in 1 BOTTLE (71610-699-80) 71610-699-92 270 CAPSULE in 1 BOTTLE (71610-699-92)

Ingredients (1)

fluoxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7088632f-e68a-40cb-a04f-3321b323a38e", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385"], "spl_set_id": ["06582152-d7d3-4e87-8c13-a4416a6ec927"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-699-30)", "package_ndc": "71610-699-30", "marketing_start_date": "20230403"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-699-53)", "package_ndc": "71610-699-53", "marketing_start_date": "20230403"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-699-60)", "package_ndc": "71610-699-60", "marketing_start_date": "20230403"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-699-70)", "package_ndc": "71610-699-70", "marketing_start_date": "20230403"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-699-80)", "package_ndc": "71610-699-80", "marketing_start_date": "20230403"}, {"sample": false, "description": "270 CAPSULE in 1 BOTTLE (71610-699-92)", "package_ndc": "71610-699-92", "marketing_start_date": "20230403"}], "brand_name": "Fluoxetine", "product_id": "71610-699_7088632f-e68a-40cb-a04f-3321b323a38e", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-699", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20221024", "listing_expiration_date": "20261231"}