fluoxetine

Generic: fluoxetine

Labeler: modavar pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler modavar pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Modavar Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72241-007
Product ID 72241-007_f35d566f-6a36-4ba8-8f78-6c1d79900e9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206993
Listing Expiration 2026-12-31
Marketing Start 2021-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72241007
Hyphenated Format 72241-007

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0372241008115 0372241007224 0372241008221 0372241009228
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 ANDA206993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72241-007-05)
  • 500 CAPSULE in 1 BOTTLE (72241-007-10)
  • 1000 CAPSULE in 1 BOTTLE (72241-007-11)
  • 30 CAPSULE in 1 BOTTLE (72241-007-22)
source: ndc

Packages (4)

72241-007-05 100 CAPSULE in 1 BOTTLE (72241-007-05) 72241-007-10 500 CAPSULE in 1 BOTTLE (72241-007-10) 72241-007-11 1000 CAPSULE in 1 BOTTLE (72241-007-11) 72241-007-22 30 CAPSULE in 1 BOTTLE (72241-007-22)

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": "f35d566f-6a36-4ba8-8f78-6c1d79900e9a", "openfda": {"upc": ["0372241008115", "0372241007224", "0372241008221", "0372241009228"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["05b0781b-50e2-4311-bde0-430b96e2ef8e"], "manufacturer_name": ["Modavar Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72241-007-05)", "package_ndc": "72241-007-05", "marketing_start_date": "20210908"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72241-007-10)", "package_ndc": "72241-007-10", "marketing_start_date": "20210908"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (72241-007-11)", "package_ndc": "72241-007-11", "marketing_start_date": "20210908"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72241-007-22)", "package_ndc": "72241-007-22", "marketing_start_date": "20210908"}], "brand_name": "Fluoxetine", "product_id": "72241-007_f35d566f-6a36-4ba8-8f78-6c1d79900e9a", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72241-007", "generic_name": "Fluoxetine", "labeler_name": "Modavar Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA206993", "marketing_category": "ANDA", "marketing_start_date": "20210908", "listing_expiration_date": "20261231"}