fluoxetine

Generic: fluoxetine

Labeler: boswell pharmacy services llc d/b/a bps wholesale
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler boswell pharmacy services llc d/b/a bps wholesale
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Boswell Pharmacy Services LLC d/b/a BPS Wholesale

Identifiers & Regulatory

Product NDC 83209-721
Product ID 83209-721_18e9f058-31ba-cc99-e063-6294a90a0fee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83209721
Hyphenated Format 83209-721

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 6 CAPSULE in 1 BLISTER PACK (83209-721-06)
  • 10 CAPSULE in 1 BLISTER PACK (83209-721-10)
  • 15 CAPSULE in 1 BLISTER PACK (83209-721-15)
  • 20 CAPSULE in 1 BLISTER PACK (83209-721-20)
  • 30 CAPSULE in 1 BLISTER PACK (83209-721-30)
  • 60 CAPSULE in 1 BLISTER PACK (83209-721-60)
source: ndc

Packages (6)

83209-721-06 6 CAPSULE in 1 BLISTER PACK (83209-721-06) 83209-721-10 10 CAPSULE in 1 BLISTER PACK (83209-721-10) 83209-721-15 15 CAPSULE in 1 BLISTER PACK (83209-721-15) 83209-721-20 20 CAPSULE in 1 BLISTER PACK (83209-721-20) 83209-721-30 30 CAPSULE in 1 BLISTER PACK (83209-721-30) 83209-721-60 60 CAPSULE in 1 BLISTER PACK (83209-721-60)

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": "18e9f058-31ba-cc99-e063-6294a90a0fee", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310385"], "spl_set_id": ["18e9f7f2-2d33-d139-e063-6294a90a3012"], "manufacturer_name": ["Boswell Pharmacy Services LLC d/b/a BPS Wholesale"]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BLISTER PACK (83209-721-06)", "package_ndc": "83209-721-06", "marketing_start_date": "20240520"}, {"sample": false, "description": "10 CAPSULE in 1 BLISTER PACK (83209-721-10)", "package_ndc": "83209-721-10", "marketing_start_date": "20240520"}, {"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (83209-721-15)", "package_ndc": "83209-721-15", "marketing_start_date": "20240520"}, {"sample": false, "description": "20 CAPSULE in 1 BLISTER PACK (83209-721-20)", "package_ndc": "83209-721-20", "marketing_start_date": "20240520"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (83209-721-30)", "package_ndc": "83209-721-30", "marketing_start_date": "20240520"}, {"sample": false, "description": "60 CAPSULE in 1 BLISTER PACK (83209-721-60)", "package_ndc": "83209-721-60", "marketing_start_date": "20240520"}], "brand_name": "Fluoxetine", "product_id": "83209-721_18e9f058-31ba-cc99-e063-6294a90a0fee", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "83209-721", "generic_name": "Fluoxetine", "labeler_name": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}