fluoxetine

Generic: fluoxetine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1609
Product ID 63629-1609_3de20a71-3538-4a28-bd40-f45a00c818c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2008-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636291609
Hyphenated Format 63629-1609

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
  • 30 CAPSULE in 1 BOTTLE (63629-1609-1)
  • 90 CAPSULE in 1 BOTTLE (63629-1609-2)
  • 60 CAPSULE in 1 BOTTLE (63629-1609-3)
  • 120 CAPSULE in 1 BOTTLE (63629-1609-4)
  • 28 CAPSULE in 1 BOTTLE (63629-1609-5)
  • 15 CAPSULE in 1 BOTTLE (63629-1609-6)
  • 100 CAPSULE in 1 BOTTLE (63629-1609-7)
  • 180 CAPSULE in 1 BOTTLE (63629-1609-8)
source: ndc

Packages (8)

63629-1609-1 30 CAPSULE in 1 BOTTLE (63629-1609-1) 63629-1609-2 90 CAPSULE in 1 BOTTLE (63629-1609-2) 63629-1609-3 60 CAPSULE in 1 BOTTLE (63629-1609-3) 63629-1609-4 120 CAPSULE in 1 BOTTLE (63629-1609-4) 63629-1609-5 28 CAPSULE in 1 BOTTLE (63629-1609-5) 63629-1609-6 15 CAPSULE in 1 BOTTLE (63629-1609-6) 63629-1609-7 100 CAPSULE in 1 BOTTLE (63629-1609-7) 63629-1609-8 180 CAPSULE in 1 BOTTLE (63629-1609-8)

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": "3de20a71-3538-4a28-bd40-f45a00c818c8", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384"], "spl_set_id": ["3ccada47-7eb9-285d-5059-06afb4466114"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63629-1609-1)", "package_ndc": "63629-1609-1", "marketing_start_date": "20220902"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63629-1609-2)", "package_ndc": "63629-1609-2", "marketing_start_date": "20220902"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (63629-1609-3)", "package_ndc": "63629-1609-3", "marketing_start_date": "20090423"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (63629-1609-4)", "package_ndc": "63629-1609-4", "marketing_start_date": "20090731"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (63629-1609-5)", "package_ndc": "63629-1609-5", "marketing_start_date": "20220902"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (63629-1609-6)", "package_ndc": "63629-1609-6", "marketing_start_date": "20220902"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63629-1609-7)", "package_ndc": "63629-1609-7", "marketing_start_date": "20220902"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (63629-1609-8)", "package_ndc": "63629-1609-8", "marketing_start_date": "20220902"}], "brand_name": "Fluoxetine", "product_id": "63629-1609_3de20a71-3538-4a28-bd40-f45a00c818c8", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-1609", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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": "20080131", "listing_expiration_date": "20261231"}