fluoxetine

Generic: fluoxetine

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-112
Product ID 16714-112_a3031cb7-423c-64e2-e1d4-2b07f2e7ba3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076006
Listing Expiration 2026-12-31
Marketing Start 2019-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714112
Hyphenated Format 16714-112

Supplemental Identifiers

RxCUI
248642 313990
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

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 ANDA076006 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-112-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-112-02)
source: ndc

Packages (2)

16714-112-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-112-01) 16714-112-02 100 TABLET, FILM COATED in 1 BOTTLE (16714-112-02)

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": "a3031cb7-423c-64e2-e1d4-2b07f2e7ba3a", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["70b4bd1b-d355-189e-a414-9fff182fd1cd"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-112-01)", "package_ndc": "16714-112-01", "marketing_start_date": "20190918"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-112-02)", "package_ndc": "16714-112-02", "marketing_start_date": "20190918"}], "brand_name": "Fluoxetine", "product_id": "16714-112_a3031cb7-423c-64e2-e1d4-2b07f2e7ba3a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "16714-112", "generic_name": "Fluoxetine", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076006", "marketing_category": "ANDA", "marketing_start_date": "20190918", "listing_expiration_date": "20261231"}