fluoxetine

Generic: fluoxetine hydrochloride

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 hydrochloride
Labeler boswell pharmacy services llc d/b/a bps wholesale
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

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

Identifiers & Regulatory

Product NDC 83209-192
Product ID 83209-192_1fd02569-04f0-e34e-e063-6394a90a227b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2024-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83209192
Hyphenated Format 83209-192

Supplemental Identifiers

RxCUI
310384
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 ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BLISTER PACK (83209-192-10)
  • 15 CAPSULE in 1 BLISTER PACK (83209-192-15)
  • 30 CAPSULE in 1 BLISTER PACK (83209-192-30)
  • 60 CAPSULE in 1 BLISTER PACK (83209-192-60)
source: ndc

Packages (4)

83209-192-10 10 CAPSULE in 1 BLISTER PACK (83209-192-10) 83209-192-15 15 CAPSULE in 1 BLISTER PACK (83209-192-15) 83209-192-30 30 CAPSULE in 1 BLISTER PACK (83209-192-30) 83209-192-60 60 CAPSULE in 1 BLISTER PACK (83209-192-60)

Ingredients (1)

fluoxetine hydrochloride (10 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": "1fd02569-04f0-e34e-e063-6394a90a227b", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384"], "spl_set_id": ["1fd00b7f-df07-455f-e063-6394a90a1f10"], "manufacturer_name": ["Boswell Pharmacy Services LLC d/b/a BPS Wholesale"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BLISTER PACK (83209-192-10)", "package_ndc": "83209-192-10", "marketing_start_date": "20240816"}, {"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (83209-192-15)", "package_ndc": "83209-192-15", "marketing_start_date": "20240816"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (83209-192-30)", "package_ndc": "83209-192-30", "marketing_start_date": "20240816"}, {"sample": false, "description": "60 CAPSULE in 1 BLISTER PACK (83209-192-60)", "package_ndc": "83209-192-60", "marketing_start_date": "20240816"}], "brand_name": "Fluoxetine", "product_id": "83209-192_1fd02569-04f0-e34e-e063-6394a90a227b", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "83209-192", "generic_name": "Fluoxetine Hydrochloride", "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": "10 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20240816", "listing_expiration_date": "20261231"}