fluoxetine

Generic: fluoxetine

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler micro labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-388
Product ID 42571-388_0770266d-0043-f296-e063-6294a90a1d1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216232
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571388
Hyphenated Format 42571-388

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0342571388300
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 ANDA216232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42571-388-01)
  • 1000 CAPSULE in 1 BOTTLE (42571-388-10)
  • 30 CAPSULE in 1 BOTTLE (42571-388-30)
source: ndc

Packages (3)

42571-388-01 100 CAPSULE in 1 BOTTLE (42571-388-01) 42571-388-10 1000 CAPSULE in 1 BOTTLE (42571-388-10) 42571-388-30 30 CAPSULE in 1 BOTTLE (42571-388-30)

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": "0770266d-0043-f296-e063-6294a90a1d1c", "openfda": {"upc": ["0342571388300"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["77b01a37-ba10-4b67-a375-244dfcd94c00"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42571-388-01)", "package_ndc": "42571-388-01", "marketing_start_date": "20230101"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (42571-388-10)", "package_ndc": "42571-388-10", "marketing_start_date": "20230101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42571-388-30)", "package_ndc": "42571-388-30", "marketing_start_date": "20230101"}], "brand_name": "FLUOXETINE", "product_id": "42571-388_0770266d-0043-f296-e063-6294a90a1d1c", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "42571-388", "generic_name": "FLUOXETINE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA216232", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}