fluoxetine

Generic: fluoxetine hydrochloride

Labeler: calvin scott & co., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler calvin scott & co., inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Calvin Scott & Co., Inc.

Identifiers & Regulatory

Product NDC 17224-171
Product ID 17224-171_f709b80f-6425-790e-e053-6394a90a17fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2015-03-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 17224171
Hyphenated Format 17224-171

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 ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE (17224-171-21)
  • 30 CAPSULE in 1 BOTTLE (17224-171-30)
source: ndc

Packages (2)

17224-171-21 21 CAPSULE in 1 BOTTLE (17224-171-21) 17224-171-30 30 CAPSULE in 1 BOTTLE (17224-171-30)

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": "f709b80f-6425-790e-e053-6394a90a17fc", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384"], "spl_set_id": ["3453755b-3ed6-47a3-b4c7-c64758e7784c"], "manufacturer_name": ["Calvin Scott & Co., Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE (17224-171-21)", "package_ndc": "17224-171-21", "marketing_start_date": "20150316"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (17224-171-30)", "package_ndc": "17224-171-30", "marketing_start_date": "20150316"}], "brand_name": "Fluoxetine", "product_id": "17224-171_f709b80f-6425-790e-e053-6394a90a17fc", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "17224-171", "generic_name": "FLUOXETINE HYDROCHLORIDE", "labeler_name": "Calvin Scott & Co., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20150316", "listing_expiration_date": "20261231"}