fluoxetine

Generic: fluoxetine

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-902
Product ID 64380-902_35d9874e-1471-484c-b625-29e70a190e10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212684
Listing Expiration 2027-12-31
Marketing Start 2024-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380902
Hyphenated Format 64380-902

Supplemental Identifiers

RxCUI
248642 313990
UPC
0364380902065 0364380903062
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 ANDA212684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64380-902-04)
  • 100 TABLET in 1 BOTTLE (64380-902-06)
  • 1000 TABLET in 1 BOTTLE (64380-902-08)
source: ndc

Packages (3)

64380-902-04 30 TABLET in 1 BOTTLE (64380-902-04) 64380-902-06 100 TABLET in 1 BOTTLE (64380-902-06) 64380-902-08 1000 TABLET in 1 BOTTLE (64380-902-08)

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": "35d9874e-1471-484c-b625-29e70a190e10", "openfda": {"upc": ["0364380902065", "0364380903062"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["ca749349-d0e1-4b7c-b4c0-e392e72cf0f6"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64380-902-04)", "package_ndc": "64380-902-04", "marketing_start_date": "20240812"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-902-06)", "package_ndc": "64380-902-06", "marketing_start_date": "20240812"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64380-902-08)", "package_ndc": "64380-902-08", "marketing_start_date": "20240812"}], "brand_name": "FLUOXETINE", "product_id": "64380-902_35d9874e-1471-484c-b625-29e70a190e10", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "64380-902", "generic_name": "fluoxetine", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOXETINE", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA212684", "marketing_category": "ANDA", "marketing_start_date": "20240812", "listing_expiration_date": "20271231"}