fluoxetine

Generic: fluoxetine

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-029
Product ID 23155-029_320829b0-51bc-41aa-99e7-d5ff1375995c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201336
Listing Expiration 2026-12-31
Marketing Start 2024-10-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155029
Hyphenated Format 23155-029

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0323155030013
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 ANDA201336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (23155-029-01)
  • 1000 CAPSULE in 1 BOTTLE (23155-029-10)
source: ndc

Packages (2)

23155-029-01 100 CAPSULE in 1 BOTTLE (23155-029-01) 23155-029-10 1000 CAPSULE in 1 BOTTLE (23155-029-10)

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": "320829b0-51bc-41aa-99e7-d5ff1375995c", "openfda": {"upc": ["0323155030013"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["6f4e4e9f-9ded-452f-b3ef-ab6aa9c72952"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (23155-029-01)", "package_ndc": "23155-029-01", "marketing_start_date": "20241013"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (23155-029-10)", "package_ndc": "23155-029-10", "marketing_start_date": "20241013"}], "brand_name": "FLUOXETINE", "product_id": "23155-029_320829b0-51bc-41aa-99e7-d5ff1375995c", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "23155-029", "generic_name": "FLUOXETINE", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA201336", "marketing_category": "ANDA", "marketing_start_date": "20241013", "listing_expiration_date": "20261231"}